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Job Description The Vice President, Biometrics will lead and oversee all biometrics activities supporting clinical development from IND-enabling studies through regulatory submission. This role is responsible for Biostatistics, Statistical Programming, and Clinical Data Management, and will serve as the functional head of Biometrics at Janux. The VP will work closely with senior leadership to shape clinical strategy, study design, regulatory planning, and data-driven decision-making. This role requires a highly strategic and collaborative leader who can also operate hands-on in a dynamic, fast-paced clinical-stage biotech environment. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Provide strategic and operational leadership for the Biometrics function, including Biostatistics, Statistical Programming, and Clinical Data Management., • Build, lead, and develop a high-performing biometrics organization, including internal staff, consultants, and external partners (e.g., CROs and vendors)., • Lead biometrics strategy and execution across clinical development programs from early development through submission readiness and post-submission support., • Serve as the biometrics functional lead on cross-functional development teams, contributing to study design, statistical strategy, endpoint selection, and key development decisions., • Act as a trusted advisor to senior leadership on statistical methodologies, data strategy, data integrity, and clinical development planning., • Oversee the design, analysis, and interpretation of clinical trials and preclinical studies, ensuring scientific rigor, regulatory compliance, and high-quality data standards., • Provide oversight and strategic guidance for statistical analysis plans (SAPs), Tables, Listings, and Figures (TLFs), clinical study reports (CSRs), integrated summaries, and regulatory submission deliverables., • Ensure all biometrics deliverables meet applicable regulatory standards and industry best practices, including CDISC, SDTM, ADaM, and related requirements., • Support and lead preparation for regulatory interactions and inspections; represent Biometrics in meetings with FDA, EMA, and other global health authorities as appropriate., • Collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Sciences, Pharmacovigilance, and Quality teams to ensure alignment on study design, execution, and data quality., • Provide oversight of CRO and vendor deliverables, including database build, CRF design, data review, programming outputs, and TLF production, ensuring quality, timelines, and cost-effectiveness., • Establish and maintain biometrics systems, standards, processes, and SOPs, including frameworks for CRF development, data collection, database management, and data governance., • Drive innovation in statistical methodology, adaptive trial design, data analytics, visualization, and technology-enabled processes to support program advancement and decision-making., • Ensure appropriate resourcing across the biometrics organization, including workforce planning, budget management, and vendor strategy., • Support business development, diligence, and strategic partnership activities as the biometrics subject matter expert., • Represent the company externally in scientific, regulatory, and industry forums, as appropriate.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS, AND ABILITIES, • PhD in Biostatistics, Statistics, or a related quantitative discipline required., • 15+ years of experience in biotechnology or pharmaceutical drug development, including significant leadership experience in biometrics., • Proven experience leading integrated biometrics functions across Biostatistics, Statistical Programming, and Clinical Data Management., • Deep experience across all phases of drug development, ideally spanning early-stage development through registration and commercialization support., • Strong background in oncology therapeutics and drug development; experience in immunology, autoimmune disease, or related therapeutic areas is highly desirable., • Demonstrated success supporting regulatory submissions and health authority interactions, including NDA/BLA filings and advisory committee preparation., • Extensive knowledge of clinical trial design, statistical methodology, adaptive designs, and applicable regulatory requirements and guidance (ICH, FDA, EMA, GCP)., • Strong technical expertise, including familiarity with SAS, R, CDISC standards, electronic data capture systems, and modern clinical data platforms., • Proven ability to build, mentor, and scale high-performing teams in a collaborative and accountable culture., • Strong executive presence with excellent communication, presentation, and influencing skills, • Demonstrated ability to operate effectively in a fast-paced, hands-on, clinical-stage biotech environment with evolving priorities., • Strong organizational skills with the ability to manage multiple programs and deadlines simultaneously., • Commitment to scientific excellence, operational rigor, and continuous process improvement., • Ability to travel up to 25% as business needs require. In addition to a competitive base salary ranging from $330,000 to $360,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location. Benefits: • Annual bonus program, • Incentive stock option plan, • 401k plan with flat non-elective employer contribution, • Comprehensive medical insurance with 90-100% employer-paid premiums, • Dental and vision insurance, • HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity), • Unlimited PTO, • Generous holiday schedule; includes summer and winter company shutdown, • Relocation assistance Schedule: • Monday to Friday Work authorization: • United States (Required) Additional Compensation: • Annual targeted bonus % Work Location: • Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required. Travel: • Up to 25% travel may be required, including domestic and occasional international travel for regulatory meetings, CRO oversight, investigator meetings, scientific conferences, and corporate activities. EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department: Regulatory Reports to: VP, Regulatory and Quality About the Role We are seeking a Senior Director of Regulatory Affairs will serve as the senior regulatory leader for Synchron’s San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. This role will own regulatory strategy for new BCI platform development, with oversight of ongoing product updates, and manufacturing-related submissions, working closely with cross-functional teams in engineering, quality, and clinical to ensure regulatory readiness at every stage of the product lifecycle. Key Responsibilities • Regulatory Strategy and Submissions, • Lead regulatory strategy and submission planning for software, firmware, and hardware for new product development programs and product updates, • Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed, • Develop and execute software and firmware regulatory strategy for complex BCI devices, including AI/ML considerations, software and firmware change management, and lifecycle documentation in compliance with applicable guidance, • Provide regulatory support for manufacturing-related activities, including process changes and design transfers, • Cross-Functional Leadership, • Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization, • Provide regulatory guidance on new product concepts, design inputs, and technology transfers, • Support project planning and roadmaps with well-defined regulatory milestones and risk assessments, • Regulatory Intelligence and Compliance, • Monitor evolving FDA regulations, guidance documents, and international standards relevant to Class III implantable devices and complex software- and firmware-driven medical technologies, • Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations and correspondence management, • Represent Synchron in FDA meetings, pre-submission interactions, and agency correspondence, • Minimal travel expected (<10% of the time). Potential planned travel for FDA meetings, cross-site collaboration, and conferences., • Perform other duties and responsibilities as assigned Required Qualifications • Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred., • 12+ years of regulatory affairs experience in the medical device industry, with progressive responsibility including demonstrated experience with complex, high-risk (Class III) active implantable neurological or cardiac devices., • Strong software and firmware regulatory expertise for complex medical devices, including experience with AI/ML-enabled features, software and firmware change management, and applicable FDA guidance, • Track record of leading FDA submissions (IDE, PMA, supplements) and managing agency interactions independently, • Familiarity with manufacturing-related regulatory considerations, including process changes and design transfers, in a device development or scale-up context, • Experience supporting new product development from concept through submission, including design control and risk management integration, • Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards, • Exceptional written and verbal communication skills; ability to translate regulatory complexity for engineering and executive audiences, • Effective time management and interpersonal skills, • Builds productive internal and external working relationships Preferred Qualifications • RAC certification (RAPS), • Experience with brain-computer interfaces, neural stimulation, or implantable neurotechnology, • Familiarity with OUS regulatory pathways (CE Mark, TGA, or similar), • Experience scaling a regulatory function at a growth-stage medical device company Key Competencies • Strong attention to detail and commitment to accuracy, • Excellent problem‑solving, • Effective written and verbal communication, • Ability to partner cross‑functionally and influence stakeholders, • Strong organizational and project management skills, with comfort operating in a lean, startup‑style environment Compensation The base salary range for this role is $210,000 – $240,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) *Intern positions not eligible • Subsidized medical and dental insurance coverage for you and your dependent(s), • Life insurance, short-term disability, long-term disability, • 401k, • Discretionary unlimited PTO, • Flexible Spending Account for you and your dependent(s), with eligible plan elections, • Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.

Job Description Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. Umoja Biopharma – Your Body. Your Hope. Your Cure. POSITION SUMMARY The Vice President, Clinical Development is a strategic and operational leader responsible for advancing the company's clinical-stage pipeline through all phases of clinical development. This role provides leadership and oversight for the Clinical Development organization, including Medical Directors and Clinical Scientists. The VP will lead the development and execution of integrated clinical development strategies, ensuring high-quality, compliant, and efficient clinical programs that support regulatory approvals and commercialization objectives. As a key member of the Clinical Development Leadership Team, this role collaborates closely with Regulatory Affairs, Translational Medicine, Research, CMC, Quality, Commercial, and Executive Leadership to drive clinical and corporate objectives. This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote on the West Coast for the right candidate with the expectation to be in Seattle 5 business days per month. CORE ACCOUNTABILITIES: Specific responsibilities include: • Lead the overall clinical development strategy for the company's portfolio, ensuring alignment with corporate and regulatory objectives., • Partner with the CMO and Executive Leadership team to define development pathways, clinical endpoints, and regulatory strategies., • Build and develop a high-performing, scalable clinical organization of Medical Directors and Clinical Scientists. Establish clear goals, metrics and development plans for team members and leaders in alignment with Umoja's values and principles., • In collaboration with the CMO, communicate the clinical vision and emerging data to the Board, investors and potential partners, helping articulate the value, differentiation and development potential of Umoja's pipeline., • Shape the long-term clinical development strategy translating emerging clinical, translational and competitive insights into indication selection, sequencing and investment recommendations., • Define the clinical path for establishing in vivo CAR-T as a new therapeutic modality, including evidence generation that differentiates Umoja from conventional autologous, allogeneic, and other in vivo cell-therapy approaches., • Evaluate emerging clinical data, competitive intelligence, and scientific developments to inform development plans., • Serve as a key contributor to portfolio prioritization, resource planning, and investment decisions., • Drive accountability, operational excellence, and cross-functional collaboration., • Ensure appropriate staffing, vendor management, and resource allocation across programs., • Ensure clinical studies are conducted on time, within budget, and in compliance with regulatory requirements., • Lead clinical governance processes, risk management, and portfolio prioritization., • Oversee safety monitoring, data quality, and clinical study reporting., • Ensure inspection readiness and compliance with GCP, ICH, FDA, and global regulations., • Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed., • Partner with Regulatory Affairs in preparing global regulatory submissions and agency interactions., • Participate in meetings with health authorities, including FDA, EMA, and other international agencies., • Support preparation of briefing documents, submission packages, and responses to regulatory inquiries., • Build and lead a network of external scientific and clinical advisors, establishing Umoja as a preferred partner for investigators, thought leaders, vendors, partners, and scientific organizations in hematologic oncology, cell therapy and autoimmune field. The successful candidate will have: • Significant experience within biotechnology, pharmaceutical, or related life sciences organizations., • Prior experience leading clinical development functions and multidisciplinary teams is highly preferred., • Demonstrated success leading clinical programs through multiple stages of development, including late-stage and registration-enabling studies., • Experience supporting regulatory interactions and submissions., • Cell and gene therapy or advanced modality experience preferred., • Hematology/oncology, immunology, rheumatology, or advanced therapeutic experience strongly preferred., • Strategic thinker with strong scientific and business acumen., • Proven ability to lead and scale high-performing teams., • Excellent communication, influence, and stakeholder management skills., • Demonstrated ability to operate effectively in a dynamic, fast-paced biotech environment. Physical Requirements: • The ideal candidate will be able to work onsite based out of our Seattle, WA office at least 2 days/week. There may be the ability to work remotely on the west coast and travel to Seattle, WA at least 5 days/month., • Ability to travel domestically and, if applicable, internationally (typically up to 30–50%, depending on role), including air travel and extended periods away from home., • Ability to attend and actively participate in external meetings, some of which may require travel., • Ability to sit for prolonged periods of time. Salary Range: $320,000 - $400,000 Benefits Offerings Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Regulatory Affairs Manager Location: Onsite - San Diego, CA Position Summary: The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances. Key Responsibilities: • Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies., • Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards., • Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements., • Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products., • Perform regulatory assessments for product changes and propose appropriate regulatory pathways., • Maintain documentation and records of all regulatory submissions and correspondence., • Support the preparation for regulatory agency meetings, audits, and inspections., • Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner. Requirements Education: • Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required., • Master’s degree preferred. Professional Experience: • 5–7 years of regulatory affairs experience within the medical device or IVD industry., • Working knowledge of 510(k) submissions and regulatory documentation processes., • Experience interacting with FDA and other regulatory agencies preferred. Skills & Competencies: • Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements., • Strong organizational and project management skills with the ability to manage multiple projects and priorities., • Excellent communication, problem-solving, and attention to detail., • Ability to work collaboratively in cross-functional teams and manage document workflows. Benefits • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials, as well as planning for future MAA/NDA/BLA(s). This role requires an independent, self-directed, and highly motivated regulatory professional. Position Responsibilities: • Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements., • Prepare and/or review CMC regulatory documents and submissions to support product development (e.g. ND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA) Provide oversight of regulatory submission content and planning, to assure technical accuracy, compliance, and completeness., • Assess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies., • Collaborate cross-functionally on the eTMF processes and compliance alignment., • Represent regulatory on study and program teams throughout study conduct and product development., • Support or lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required., • Review relevant clinical and CMC documents (protocol, informed consent form, investigator's brochure, and site quality documentation, and required regulatory forms) for regulatory compliance and consistency across submission components., • Maintain current knowledge of US and international CMC regulation requirements that apply to company products and processes., • Support or lead development of internal Erasca SOPs and processes, as needed., • May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs project lead., • Perform all duties in keeping with the Company's core values, policies, and all applicable regulations. Position Requirements: • Undergraduate degree required; advanced degree preferred., • 5+ years of experience in pharmaceutical or biotech regulatory affairs or related areas, including regulatory affairs for oncology products., • Ability to translate regulatory requirements into practical workable plans., • Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies., • Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail., • Ability to build strong relationships with co-workers of various backgrounds and expertise., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment., • Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems., • Strong learning orientation, curiosity, and commitment to science and patients. The anticipated salary range for this position is $175,000 to $205,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job Description The Associate Director, Clinical Operations will be responsible for managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations., • Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards., • Manage, mentor, and support direct reports, fostering professional development and team performance., • Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection., • Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals., • Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented., • Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF)., • Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders., • Work closely with internal stakeholders including Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs., • Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement., • Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings., • Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance., • Willingness to travel up to 15% for site visits, vendor meetings, and conferences., • Other activities as assigned. In addition to a competitive base salary ranging from $175,000 to $200,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location. Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionDescription: The Associate Director, Medical Writing & Scientific Communications will be a key member of the Medical Affairs organization, responsible for developing and executing strategic scientific communication initiatives that support clinical development, medical affairs priorities, and commercial launch readiness. In this role, the Associate Director will lead the creation of high-quality, scientifically rigorous medical communications across publications, congress activities, scientific platforms, advisory boards, and healthcare provider engagement initiatives. The ideal candidate brings deep expertise in medical writing and scientific communications within the biotechnology or pharmaceutical industry, demonstrated ability to translate complex clinical data into meaningful scientific narratives, and experience collaborating cross-functionally with Medical Affairs, Clinical Development, Regulatory Affairs, and external scientific experts. This is a unique opportunity to build a foundational scientific communications capability within a growing organization and make a meaningful impact on advancing innovative therapies for patients living with chronic disease. Essential Duties and Responsibilities The main responsibilities of this role include: • Develop and execute strategic medical writing and scientific communication plans aligned with Medical Affairs objectives and company priorities, • Lead the development of scientific communication deliverables, including peer-reviewed manuscripts, abstracts, posters, oral presentations, scientific slide decks, advisory board materials, and medical education resources, • Partner with Medical Affairs leadership and cross-functional stakeholders to establish scientific narratives, evidence communication strategies, and disease-state education platforms, • Support publication planning activities, including development and execution of publication plans in collaboration with internal stakeholders, external authors, and medical writing agencies, • Ensure scientific communications are accurate, balanced, compliant, and aligned with applicable guidelines, including Good Publication Practice (GPP) and International Committee of Medical Journal Editors (ICMJE) recommendations, • Translate complex clinical trial data, scientific literature, and healthcare trends into clear and compelling communications for healthcare professionals, investigators, and internal stakeholders, • Support medical affairs activities including:, • Medical Science Liaison training and scientific preparation, • Investigator meetings, • Advisory boards, • Congress planning and execution, • Medical information resources, • Internal scientific communications, • Collaborate closely with Clinical Development, Regulatory Affairs, Biostatistics, Commercial, Market Access, and other internal partners to ensure consistency of scientific messaging, • Manage external medical writing agencies, consultants, and scientific communication vendors, • Establish scalable medical writing processes, templates, and best practices to support a growing Medical Affairs organization, • Lead and/or contribute to cross-functional project teams supporting scientific communications strategy and execution, • Maintain and continuously enhance scientific expertise through ongoing review of clinical data, scientific literature, healthcare trends, and competitive intelligence, • Complete all required administrative duties, training, and compliance-related activities in a timely manner, • Other duties as assigned Requirements: Education and Experience • Pharm.D., Ph.D., M.D., D.O., or other advanced scientific degree preferred, • Minimum of 5 years of progressive experience in medical writing, scientific communications, medical affairs, or related roles within a biotechnology or pharmaceutical organization, • Demonstrated experience developing peer-reviewed publications, scientific congress materials, and clinical communication deliverables, • Current experience supporting Medical Affairs, Scientific Affairs, Clinical Development, or related functions within the biotechnology or pharmaceutical industry, • Proven scientific expertise in obesity, cardiometabolic disease, metabolic disorders, or related therapeutic areas preferred, • Strong understanding of clinical trial design, interpretation of clinical data, and evidence-based scientific communication Knowledge and Skills • Exceptional scientific writing, editing, and communication skills with strong attention to detail, • Ability to synthesize complex scientific information and communicate actionable insights to diverse audiences, • Experience developing strategic scientific narratives and communication platforms, • Strong knowledge of publication standards, including GPP and ICMJE guidelines, • Ability to manage multiple projects, priorities, and timelines in a fast-paced environment, • Strong analytical, organizational, and problem-solving skills, • Demonstrated ability to collaborate effectively with internal and external partners, • Self-motivated individual with an entrepreneurial mindset and ability to operate independently, • Strong interpersonal skills and professional demeanor, • Excellent verbal and written communication skills, • Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel), collaboration platforms, and virtual communication tools VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Salary Description $170,000.00 - $190,000.00 annual salary

Job Description About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com. Job Summary: • The Supply Chain Buyer/Planner is responsible for leading end-to-end inventory and materials management in support of a GMP-regulated (and non-GMP) biologics/pharmaceutical manufacturing environment. This role will own the full Raw Material lifecycle—from raw material planning and ordering through inventory control—ensuring uninterrupted, compliant, and cost-effective material flow to support clinical Manufacturing, Analytical Development, and Process Development., • This role requires close collaboration with internal and external partners—including Manufacturing, Process Development, Analytical Development, QA/QC and raw material suppliers—as well as internal stakeholders across, Finance, procurement Manufacturing, and Regulatory Affairs, to maintain supply continuity, regulatory compliance, and operational excellence. Duties/Responsibilities: • Manage an End-to-End inventory management program through collaboration with external partners (Contract Manufacturing Organizations, External Biorepositories, Raw Material suppliers)., • Manage a detailed End-to-End MRP process including the establishment of risk-based inventory targets., • Support the S&OP process through End-to-End supply planning and scenario analysis., • Support Raw Material risk assessment and Raw Material Qualification activities as part of BLA readiness activities., • Support the establishment of a supplier management program with external vendors., • Develop and maintain appropriate GMP controlled documents (i.e., SOPs, WIs, and Forms)., • Coordinate various temperature controlled non-clinical shipments of raw materials to support internal manufacturing., • Creation and management of PO’s in accordance to department budget and invoicing support., • Lead or support supplier/vendor selection, onboarding, and periodic performance/business reviews (scorecards, SLAs, corrective actions)., • Manage supplier quality agreements and change control notifications (e.g., raw material or CMO process changes) in partnership with Quality Assurance., • Own inventory accuracy activities — cycle counts, physical inventories, discrepancy investigations and CAPAs., • Support import/export and customs compliance for international raw material and drug substance/product shipments., • Track and report on key supply chain metrics (OTIF, lead times, inventory turns, days of supply) to leadership., • Participate in deviation/investigation and CAPA processes tied to supply chain or receiving issues (e.g., temperature excursions, damaged goods)., • Support tech transfer and scale-up activities by ensuring raw material/consumable supply readiness for new sites or processes., • Manage supplier risk mitigation planning (single-source risk, allocation, dual-sourcing strategies, safety stock)., • Partner with Finance on accruals, purchase price variance, and cost-savings initiatives., • Support internal and external audits/inspections (customer, regulatory) related to purchasing and inventory. Requirements: • Bachelor’s Degree in Life Sciences, Supply Chain Management, or related discipline; advanced degree preferred., • 8+ years of relevant experience in inventory management, planning, or supply chain in a biotech or pharmaceutical company, preferably in handling cell therapy or other similarly complex products., • Extensive quality and compliance background in a clinical GMP operational environment, including 3+ years prior experience in commercial or clinical GMP environment., • Ability to execute strategic objectives by focusing on critical near-term priorities while building toward long-term supply chain robustness for reliable delivery of complex treatments to patients., • Excellent analytical and problem-solving skills, with the ability to interpret complex data, make data-driven decisions, and clearly articulate business rationale and implications., • Excellent planning, coordination, and time management skills; you translate high level goals into plans, collaborate and adapt to meet objectives and timelines., • Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership., • A desire and ability to work in a dynamic, collaborative environment; you build productive and healthy relationships within and across functions., • Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; you share feedback and constructively challenge and accept challenges to generate the best ideas to advance project and company goals., • Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel., • Experience with GMP documentation practices (good documentation practices, deviation/CAPA systems)., • Proficiency in Excel/data analysis tools; experience building dashboards or reports, • Negotiation experience with suppliers on pricing, lead times, and contract terms. Preferred Qualifications: • Experience with Allogeneic Cell Therapy biotechnology companies., • ERP system experience (i.e. Netsuite)., • APICS/ASCM certification (CPIM, CSCP) or similar supply chain credential. Experience supporting BLA/regulatory filings or commercial launch readiness from a supply chain perspective. In addition to a great culture, we offer: • A beautiful facility, • An entrepreneurial, highly collaborative, and innovative environment, • Comprehensive benefits, including:, • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $ 130,000 - $145,000 annually. Exact compensation may vary based on level, skills and experience.

Job Description Lead the global chemistry, manufacturing, and controls (CMC) strategy, process optimization, and contract manufacturing network for therapeutic oligonucleotides to ensure the seamless, compliant supply of drug substance and drug product across clinical pipeline phases. Accountabilities: • Design and execute phase-appropriate global CMC development strategies for therapeutic oligonucleotides from late-stage discovery through advanced clinical testing to achieve corporate pipeline milestones., • Direct external Contract Development and Manufacturing Organizations (CDMOs) and analytical testing laboratories, overseeing technology transfers, process scale-ups, and cGMP campaigns., • Optimize solid-phase oligonucleotide synthesis, cleavage, deprotection, purification, and lyophilization processes to maximize production yields and ensure operational efficiency., • Oversee the development, qualification, and validation of analytical methods for release testing, stability monitoring, and impurity characterization to maintain high product quality., • Partner with the Quality Assurance team to review and approve master batch records, executed runs, and stability protocols to ensure unconditional compliance with cGMP and phase-appropriate regulatory guidelines., • Author, review, and finalize CMC technical sections (Module 3) for global regulatory filings (including INDs, IMPDs, and NDAs) to facilitate rapid health authority approvals., • Formulate technical data packages and precise written responses to CMC-related inquiries from global regulatory agencies (including the US FDA and EMA)., • Serve as the primary CMC representative on cross-functional program teams, collaborating closely with Discovery Biology, Translational Research, Regulatory Affairs, and Clinical Operations to ensure clinical trial material readiness., • Forecast long-term chemical material needs and manage chemical raw inventory pools (including amidites and solid supports) to de-risk global clinical supply chains. Requirements Required Knowledge and Experience • Demonstrated technical depth leading outsourced cGMP manufacturing operations and managing technology transfers with international CDMOs., • Proven competence in therapeutic oligonucleotide chemistry (including ASOs, siRNA, and sgRNA), phosphoramidite workflows, conjugation strategies, and advanced purification techniques., • Advanced working knowledge of analytical chemistry specific to oligonucleotides, with deep expertise in sequence confirmation, impurity profiling, and stability control strategies., • Thorough understanding of global regulatory guidelines (ICH, FDA, and EMA) regarding the development, characterization, and manufacturing specifications of synthetic oligonucleotides., • Exposure to or direct experience tracking targeted delivery systems for oligonucleotides, such as GalNAc conjugates or lipid nanoparticles (LNPs)., • Advanced educational background (PhD level preferred) in Organic Chemistry, Biochemistry, Chemical Engineering, or a highly related life sciences discipline. HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development. At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.

Job Description ABOUT IMMUNEERING Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture. POSITION SUMMARY This is a foundational hire. As Immuneering’s first US-based field medical employee, this role will establish the company’s scientific presence with key opinion leaders and academic oncology centers nationwide. This role is best suited for a senior MSL who is willing to engage with KOLs enthusiastically and build a rapport with the scientific community, with the strategic vision and potential to grow into a leadership position within a lean, mission-driven organization. The selected MSL may have the opportunity to assist with the company’s international MSL buildout across Western Europe, Central-Eastern Europe, and the Australia/APAC region, and could quickly step into the role of Field Medical Director. US Field Medical Affairs • Develop and manage peer-to-peer scientific relationships with oncology KOLs, academic investigators, and institutional stakeholders at priority centers including MSKCC, City of Hope, OHSU, and the SCRI/USON/OneOncology networks and others., • As a major priority, this individual will support investigator identification and engagement for MAPKeeper 301 Phase 3 enrollment; facilitate site activation and scientific readiness at high-enrolling centers., • Deliver accurate, balanced, and compliant scientific exchange on Immuneering’s Deep Cyclic Inhibition mechanism, MAPKeeper in metastatic pancreatic cancer, atebimetinib + cemiplimab in RAS-mutant NSCLC and other possible studies related to the MAPK pathway., • Respond to unsolicited medical information requests from healthcare professionals in accordance with FDA guidelines on scientific exchange., • Generate and communicate field insights — including HCP perspectives, competitive intelligence, and clinical practice patterns — to Medical Affairs, Clinical, and Commercial stakeholders., • Provide flexible US territory coverage (East, Central/South, West) based on enrollment priorities and KOL geography., • Represent Immuneering at national and regional oncology congresses (possibly including ASCO, AACR, ESMO and others). Global MSL Network Leadership • Partner with Medical Affairs leadership to develop scientific messaging frameworks, training curricula, and field activity standards for the global consultant network., • May quickly transform into a leadership position as the Field Medical Director, which would entail managing the buildout of Immuneering’s OUS consultant MSL network across the UK/Western Europe, Central-Eastern Europe (Poland, Czech Republic, Hungary, Romania), and Australia/APAC., • Contribute to MSL infrastructure, SOPs, and reporting frameworks as Immuneering scales toward commercialization or partnership. Education • Advanced degree in a health science discipline (MD, PharmD, PhD, or MSN/NP/PA with oncology specialization), • 3–5+ years of MSL experience in oncology; prior experience at a biotech or clinical-stage company strongly preferred Technical / Soft Skills Required • Established KOL relationships in pancreatic cancer, thoracic oncology, or a closely adjacent tumor type, • Deep understanding of clinical trial design, oncology drug development, and FDA-compliant scientific exchange, • Ability to translate complex mechanistic science (RAS/MAPK pathway biology, adaptive resistance, combination strategies) for diverse oncology audiences, • Willingness and ability to travel 50–60% domestically; occasional international travel for global team alignment and congresses, • US-based; eligible to work in the United States without sponsorship Preferred • Background in RAS/MEK pathway biology, GI oncology, or thoracic oncology, • Experience supporting Phase 2 or Phase 3 clinical trial enrollment as an MSL, • Prior experience in a lead MSL, field medical director, or senior leadership field medical role, • Familiarity with medical affairs operations in an international or multi-regional context, • Experience working with or coordinating medical affairs consultants or CRO-based MSL models EQUAL OPPORTUNITY EMPLOYER Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Regulatory Affairs Specialist/Senior Specialist \n Hybrid, San Diego \n \n We're currently supporting A global healthcare diagnostics organization focused on developing and delivering innovative diagnostic solutions that support disease detection, patient monitoring, and clinical decision-making. The business operates within a highly regulated environment, with a strong focus on quality systems, regulatory compliance, product development, and advancing next-generation diagnostic technologies. \n \n They're currently seeking a Regulatory Affairs Specialist/Senior Specialist who will be responsible for preparing and filing complex pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU and other international regulatory bodies. Ideally someone with experience in the diagnostics or biotech indsutry. \n \n Key Responsibilities: \n\n • Lead preparation, submission, and lifecycle management of global regulatory submissions (FDA, EU Notified Bodies, and other international authorities) for IVD products.\n, • Develop regulatory strategies for new product development, product changes, and post-market activities, providing guidance to cross-functional teams throughout the product lifecycle.\n, • Manage health authority interactions, submission timelines, agency correspondence, commitments, and responses while ensuring compliance with applicable regulations and guidance.\n, • Partner with R&D, Quality, Clinical, Engineering, and other SMEs to compile technical documentation, review scientific data, and ensure regulatory requirements are addressed.\n, • Assess regulatory impact of product changes, support change control activities, inspections, audits, and risk mitigation initiatives.\n, • Provide regulatory expertise on quality system documentation, technical reports, validations, and submission content.\n, • Drive projects independently, communicate status updates to leadership, identify process improvements, and support continuous improvement initiatives.\n, • Mentor junior regulatory team members and provide guidance on regulatory processes and best practices.\n\n \n Required Skills & Experience: \n\n • 4+ years within a regulated medical device, IVD, pharmaceutical, or biologics environment\n, • Strong knowledge of IVD regulations, reagent chemistry, laboratory automation, and software-enabled diagnostic platforms.\n, • Experience managing complex regulatory submissions and communicating with FDA, EU authorities, and international regulatory agencies.\n, • Ability to interpret technical/scientific data and translate complex information into clear regulatory documentation.\n, • Strong project management, analytical, problem-solving, and stakeholder management skills.\n, • Excellent written and verbal communication skills with the ability to influence cross-functional teams.\n, • Experience with regulatory documentation systems, change control processes, and tools such as SAP, JIRA, and document management platforms.\n, • Bachelor’s degree in Life Sciences, Engineering, or related scientific discipline required.\n\n \n Apply today to learn more or reach out directly to rbanton@barringtonjames.com

About Cymbiotika \n At Cymbiotika, we believe that wellness starts with trust. That’s why we’re committed to creating supplements that are not only effective but also transparent. From the moment you pick up one of our products, you’ll know exactly what’s inside—no hidden ingredients, no confusing labels. We take pride in using only the highest-quality ingredients, carefully sourced and backed by science, to ensure you’re getting the best of nature and innovation in every supplement. \n \n We understand that health is personal, which is why our supplements are designed to work with your body, not against it. By focusing on bioavailability and using advanced liposomal delivery systems, we ensure that your body can absorb and use the nutrients to their fullest potential. Our goal is simple: to help you feel your best, with products you can trust, made with ingredients you feel good about. \n \n With Cymbiotika, you’re not just taking a supplement—you’re joining a community of people who value wellness, science, and the power of transparency. We’re here to empower you on your journey to better health, every step of the way. \n \n Role Overview \n Cymbiotika is seeking an experienced Regulatory Compliance Specialist to support product compliance and regulatory initiatives across dietary supplements, nutritional products, foods, and cosmetics. This role will help ensure products are manufactured, labeled, and marketed in compliance with applicable U.S. and international regulations, including 21 CFR Parts 111, 117, and 110, the FD&C Act, and the Fair Packaging and Labeling Act. \n \n The Specialist will support regulatory assessments, product and label compliance, registrations, certifications, inspections, recalls, consumer complaints, and other regulatory programs. This role will collaborate cross-functionally with Legal, Product Development, R&D, Quality, and other teams to provide practical regulatory guidance and support Cymbiotika’s continued growth and international expansion. \n \n The ideal candidate brings experience with regulatory compliance in the dietary supplement, food, cosmetics, or consumer products industry and strong communication and cross-functional collaboration skills. \n \n Key Responsibilities \n Regulatory Compliance & Product Assessment \n\n • Support regulatory compliance for dietary supplements, nutritional products, foods, and cosmetics, including applicable FDA regulations under 21 CFR Parts 110, 111, and 117, the Federal Food, Drug, and Cosmetic Act, Fair Packaging and Labeling Act, Prop 65, and applicable international regulations.\n, • Conduct preliminary regulatory assessments of formulas, ingredients, finished products, and product innovations to identify potential compliance considerations.\n, • Review formulas, raw materials, finished product specifications, and applicable regulatory requirements to support product compliance.\n, • Monitor regulatory changes, guidance, standards, and industry best practices and communicate relevant updates to internal stakeholders.\n\n \n Labeling & Marketing Compliance \n\n • Review new and revised product labels, packaging, artwork, and supporting documentation to ensure compliance with applicable regulatory requirements.\n, • Collaborate with Marketing and Product Development to review product claims, labeling, and consumer-facing materials.\n, • Provide regulatory guidance on product positioning, claims, and labeling throughout the product lifecycle.\n\n \n International Registrations & Regulatory Documentation \n\n • Support product registrations, notifications, certifications, and other regulatory submissions for applicable international markets, including Health Canada, UAE, and the UK.\n, • Maintain regulatory files, product documentation, certifications, specifications, and other compliance records.\n, • Manage and coordinate required regulatory reporting, including annual and periodic reporting requirements.\n\n \n Vendor & Manufacturing Compliance \n\n • Coordinate with third-party manufacturers, testing laboratories, and vendor partners to obtain and maintain required regulatory documentation.\n, • Support product testing requirements, facility certifications, audits, GMP, ISO, and other applicable compliance requirements.\n, • Build strong working relationships with third-party manufacturers and testing facilities to support ongoing product compliance.\n\n \n Regulatory Programs & Process Management \n\n • Develop, maintain, and update regulatory SOPs, processes, and documentation to support company policies and applicable regulations.\n, • Maintain systems for tracking regulatory requirements, changes, and updates.\n, • Support regulatory responses and documentation related to audits, inspections, recalls, complaints, and other compliance matters.\n, • Support regulatory strategy for assigned projects by identifying potential regulatory requirements, risks, and considerations.\n, • Collaborate with internal and external regulatory counsel as needed.\n, • Identify emerging regulatory trends and communicate potential impacts and proactive compliance considerations to internal stakeholders.\n\n \n Qualifications \n\n • 4+ years of Regulatory Affairs or Regulatory Compliance experience, preferably within the dietary supplement, nutritional, food, or consumer products industry.\n, • Strong knowledge of FDA 21 CFR Parts 110, 111, and 117, FPLA, FD&C Act, Prop 65, and applicable Health Canada requirements.\n, • Experience with formula, ingredient, label, and claims review.\n, • Experience supporting international regulatory requirements, including Health Canada.\n, • Experience developing and implementing regulatory SOPs and compliance processes.\n, • Strong attention to detail and ability to collaborate cross-functionally with R&D, Quality, Legal, Marketing, and external partners.\n\n \n Nice to Have / Preferred Qualifications \n\n • Self-motivated, able to manage multiple projects, and know how to prioritize. Does not have to wait for directions,\n, • Must have experience working in start up like culture in a fast-paced environment\n, • Excellent team player with a demonstrated ability to successfully participate in cross-functional teams, with the ability to summarize and communicate risk and technical details in a business-friendly way.\n, • Ability to communicate effectively, orally and in writing, with leadership, employees and all other internal and external contacts.\n, • Strong attention to detail and a proven ability in managing time and tasks associated with fast-paced organization.\n, • Ability to demonstrate accuracy and thoroughness, looking for ways to improve processes and procedures.\n, • Ability to think strategically and be extremely detail oriented.\n, • Demonstrated proficiency in Google Workspace, MS Office Suite, and ideally, NetSuite.\n\n \n Work Location & Schedule \n This position follows an enforced hybrid schedule, requiring team members to be present in our San Diego, California office at least four days per week (Monday–Thursday). Fridays are available for remote work. This role also requires attendance at all in-person monthly team meetings and quarterly company events. \n \n Physical Requirements \n This role primarily involves office-based work and requires the ability to occasionally lift, carry, or move items up to 20–30 pounds, such as files or office supplies. Employees should be able to sit or stand for extended periods and perform frequent computer-based tasks, including prolonged exposure to a computer screen. \n \n Compensation & Total Rewards \n The salary range for this position is $110,000 - 125,000 annually. Final compensation will be determined based on experience, skills, and qualifications relevant to the role. \n \n Cymbiotika offers a comprehensive total rewards package designed to support employee wellness, growth, and work-life balance. Benefits include medical, dental, and vision coverage with employer-paid plan options, 401(k) with company match, paid holidays and PTO, flexible work-from-home Fridays, wellness and fitness perks, employee product discounts, catered team lunches, team-building events, and additional lifestyle benefits! \n

Responsible for developing strategy and operating plans for Clinical QA, and establishing compliance, procedures, and quality leadership. Responsible for building and leading a team of highly trained and skilled quality managers, specialists and associates in order to implement the quality systems and perform activities necessary to ensure compliance and to ensure QA support of clinical study teams. Leads the company through pre-approval inspections and clinical audits. Coordinates interdepartmental activities both internally and externally with regulatory, clinical, drug safety, and medical affairs to ensure clinical activities and internal functions meet quality standards and reflect risk-based principals. Ensures budget, schedules, and department performance requirements are met. Develop and executive strategy for Clinical QA and establish strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives Lead effort in developing, implementing and communicating of the GCP QA vision, goals, core capabilities, and value while championing a strong Quality Culture Partner with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs stakeholders regarding compliance issues and provide quality guidance and expert interpretation of GCP regulatory requirements and expectations Responsible for preparations and direct participation in regulatory inspections, which may include reviewing inspection readiness planning, mock inspections, performance of pre-approval inspections, and risk-based management of program inspection quality events Leads in the development, implementation, and enhancements to the clinical QMS Participates in the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical laboratories, and CROs Monitors the regulatory status of principal investigators and intervenes when sub-optimal performance is identified. Assists in remediation and corrective action plans to ensure all parts of the study are conducted properly Supports investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities Develops metrics and trending of compliance activities for Clinical Quality Assurance and communicate these to upper management as necessary Performs investigator site and vendor audits to assess the integrity of the study data and to determine if studies are being conducted in compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures Directs and oversees compliance activities related to drug safety and pharmacovigilance, phase IV studies and investigator-initiated trials Oversees and may perform the internal audits designed to determine if policies/procedures, systems, reporting and/or the conduct of the investigational studies are executed with compliance to GCP principles/regulations Other duties as assigned RN, BSN, BS/MS, or BA degree or equivalent experience in scientific or health care field AND 12+ years of industry experience including GCP leadership roles within a development and commercial GCP environments. Extensive GCP audits and inspections or related experience required. Experience with developing and implementing GCP QA systems, process' and procedures. Previous managerial experience also required. OR Masters Degree in similar field as noted above AND 10+ years of experience as noted above Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact Excellent interpersonal skills and competent confident communication when interacting with regulatory authorities as well as internal leaders and external partners Analyzes complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups Ability to mentor, be a trusted advisor, and an advocate for Quality with the ability to influence change and invest deeply in the company mission Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated a record of overcoming resistance to change and driving the adoption of new processes from a position of indirect or informal authority Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, with an enthusiastic, optimistic outlook, and a collaborative style Ability to integrate and apply feedback in a professional manner Holds self and others accountable for adherence to high work and ethical standards In-depth knowledge of all Clinical Trial related FDA regulations, ICH Guidelines, and experience with international GCP regulations and guidelines is required Ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to investigator sites as well as management Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and implementation Broad understanding of domestic and international regulations and guidance documents, with a focus on FDA & EMA regulations Broad pharmaceutical industry experience with a working knowledge of quality systems and regulatory compliance requirements for clinical quality assurance Solid knowledge of all regulations pertaining to GxP's and current industry trends as related to pharmaceutical, biological and gene therapy products Strong knowledge and expertise in GCP, as well as GLP and/or GMP systems throughout the product lifecycle Demonstrated analytical ability, strong leadership skills, exceptional communication skills, creativity, and the ability to effectively manage and implement multiple projects Ability to solve problems and troubleshoot issues Expert at managing complex and multiple work streams in changing circumstances Proven ability to cultivate and develop relationships with cross functional teams and vendors Demonstrated leadership ability to identify, manage and develop QA teams

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. The Vice President of Clinical Solutions Product Development will lead the end-to-end development of Illumina's next generation sequencing (NGS) clinical assay product portfolio, translating scientific innovation into clinically and commercially viable products for use in global markets. This executive role is responsible for strategy, execution, and cross functional leadership across product development teams, from early concept through regulatory approval and commercialization readiness, as well as on market sustainment. The clinical markets are the one of the largest growth segments at Illumina and include reproductive health, genetic disease and oncology. • Responsible for overseeing RUO and IVD product development teams as well as on market-support for clinical assay and next-generation sequencing library preparation products., • Works closely with partners across the Clinical Solutions Leadership, including Medical Affairs, Regulatory, Quality, Operations and Commercial to deliver new products and execute on our long term strategy., • Partners with R&D groups, Medical Affairs, and Product Management on future strategy and clinical needs in developing products within Oncology, Reproductive Health and Genetic Disease testing areas., • Partners with Product Management and Medical Affairs to translate technical and clinical roadmaps into product roadmaps, working together to prioritize and execute on the portfolio., • Partners with R&D teams for platforms and software to ensure seamless integration of clinical assays into Illumina's platforms and software systems to create full end-to-end solutions., • Manages a team of directors and/or high-level individual contributors who manage a larger R&D organization. Works through managers and their teams to develop a highly engaged and high performing team., • Works with business development teams on developing and executing on strategic partnerships., • Regularly participates in customer interactions alongside R&D groups and Medical Affairs. Provides direct consultation for clinical customers on on-market products in partnership with Medical Affairs, • Ensures compliance with regulatory and quality standards for IVD products for different geography regulatory standards (FDA, IVDR, etc.), • Manages budgets, timelines, and resource allocation., • Develops and maintains relationships with key opinion leaders and attends and presents at scientific meetings and national and international congresses to ensure Illumina's continued technical and scientific leadership, • Advanced degree in life sciences (PhD or MD) very strongly preferred., • Requires a Bachelor's degree and a minimum of 20 years of related experience, with 15+ years of leadership experience. P&L management experience is preferred., • Experience in developing molecular diagnostics technology and in high-complexity clinical laboratory settings is preferred., • Deep understanding of IVD development including regulatory processes in US and European markets, • Proven track record advancing assays through clinical development and toward regulatory approval. Deep understanding of development of assays and library prep for next generation sequencing., • Strong strategic thinking, executive communication, and decision-making skills., • Experience building and leading multidisciplinary teams. The estimated base salary range for the Vice President, Clinical Solutions Product Development role based in the United States of America is: $295,400 - $443,200. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long-term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com.

San Diego - A little bit of something for everyone! The Community San Diego, CA As if all that sunshine weren't enough, San Diego is a waterfront city with top-notch restaurants, beautiful ocean-sprayed vistas, neighborhoods that are steeped in history and culture, and a centrally located urban park. Whether you're spending your time indulging in the city's myriad of beaches and surf spots, visiting the aquatic attractions SeaWorld San Diego and Mission Bay Aquatic Park, or exploring the inland offerings of the city, San Diego will not disappoint. Take a closer look at what can be experienced in San Diego here! Airport Information: San Diego International Airport The closest major airport for these facilities would be the San Diego International Airport which supports 40 non-stop flights to over 70 locations across the United States. For more information about the airport, check out their website here! About the Facility San Diego VAMC The San Diego VAMC is a large medical facility located in La Jolla, California, that provides healthcare to veterans. It includes a 350-bed main hospital, the Jennifer Moreno Department of Veterans Affairs Medical Center, as well as several community clinics throughout San Diego County and it offers a wide range of medical services, including inpatient and outpatient care, surgery, mental health services, and specialty care. Facility Address: 3350 La Jolla Village Drive San Diego, CA 92161 The CNA assists patients with daily activities like dressing, bathing, eating, and getting around. Help patients maintain good hygiene by assisting with tasks like brushing teeth and washing hair. Keep an eye on patients' well-being and report any changes in temperature, mood, or pain to nurses. The CNA assists nurses with preparing patients for tests, treatments, and surgery. This might involve taking vital signs, collecting samples, and changing dressings. Help create a safe environment for patients by preventing falls and responding calmly to emergencies. Talk clearly and kindly with patients, nurses, and other healthcare professionals. Treat patients with dignity and respect their privacy. Accompany patients on trips within the hospital for tests or treatments. Recognize and take appropriate action in emergency situations. The CNA works alongside nurses and other healthcare providers to ensure patients receive the best possible care. Current certification as a CNA by the State Department of Consumer Affairs. A minimum of one (1) year direct patient care experience within the last three (3) years. Has and maintains current BCLS certification. Can provide nursing care for adult medical and surgical patients. Must have US citizenship. Must have COVID Vaccine Certification. KurzSolutions is committed to improving health outcomes by providing well-managed companies with the top healthcare talent in the market. KurzSolutions is an Equal Opportunity Employer. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.

San Diego, CAClinical – Clinical Operations /Full-Time /HybridThe Senior Clinical Trial Manager will be responsible for managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech.ESSENTIAL FUNCTIONS AND RESPONSIBILITIESLead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards.Manage, mentor, and support direct reports, fostering professional development and team performance.Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection.Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals.Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented.Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.Work closely with internal stakeholders including Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs.Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement.Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings.Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.Willingness to travel up to 15% for site visits, vendor meetings, and conferences.Other activities as assigned.$165,000 - $180,000 a yearIn addition to a competitive base salary ranging from $165,000 to $180,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.Job Type: Full-timeBenefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistanceSchedule:· Monday to FridayWork authorization:· United States (Required)Additional Compensation:· Annual targeted bonus %Work Location:· On site (San Diego, CA)EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Quality Engineer (New Product Development) Quality Location: San Diego, CA (On-site) Employment Type: Full-Time About the Role As Senior Quality Engineer (New Product Development), you will serve as the Quality lead across Synchron’s product development programs, partnering with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and Operations to ensure quality is built into products from concept through commercialization. You will lead Design Quality activities, ensure compliance with FDA, ISO 13485, ISO 14971, and applicable international regulations, and facilitate successful transfer of new products into manufacturing. You will also provide operational quality support during pilot builds and early production while contributing to the development and continuous improvement of Synchron’s Quality Management System. Key Responsibilities Design Quality & New Product Development • Serve as the Quality representative on cross-functional product development teams from concept through commercialization., • Ensure compliance with Design Controls in accordance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulations., • Lead Design Quality deliverables including:, • Design Reviews, • Design Verification & Validation (V&V), • Design History File (DHF) development, • Traceability, • Engineering Change Assessments, • Facilitate product risk management activities in accordance with ISO 14971, including hazard analyses, risk assessments, FMEAs, and verification of risk controls., • Review and approve product requirements, specifications, protocols, reports, drawings, and engineering documentation to ensure quality and regulatory compliance., • Collaborate with engineering teams to establish critical quality attributes, acceptance criteria, and design inputs/outputs., • Drive Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Quality (DFQ) principles throughout development., • Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits.Design Transfer & Manufacturing Readiness, • Partner with R&D and Manufacturing Engineering to execute successful design transfer into production., • Develop manufacturing quality strategies including Process FMEAs, Control Plans, inspection strategies, and manufacturing quality gates., • Support process validation activities (IQ/OQ/PQ), equipment qualification, and pilot manufacturing builds., • Evaluate manufacturing readiness and identify quality risks prior to product launch., • Support engineering changes through impact assessments and change control activities.Operations & Supplier Quality, • Collaborate with Operations and Supplier Quality to qualify suppliers and contract manufacturers supporting new product development., • Review supplier validation activities, incoming inspection strategies, and quality documentation., • Support investigations involving nonconforming materials, manufacturing deviations, and CAPAs associated with prototype and pilot production., • Monitor quality metrics during new product introduction (NPI) and drive continuous improvement initiatives.Quality Systems & Regulatory Support, • Author and maintain Design Quality documentation including:, • Design Plans, • DHFs, • Risk Management Files, • SOPs, • Quality Plans, • Verification & Validation protocols and reports, • Support Regulatory Affairs during submissions by ensuring quality documentation is complete and inspection-ready., • Participate in internal audits, supplier audits, FDA inspections, and Notified Body audits., • Contribute to continuous improvement of Synchron’s Quality Management System. Required Qualifications • Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field, • 7+ years of Quality Engineering experience in an FDA-regulated medical device environment with demonstrated experience supporting new product development, design controls, risk management, verification & validation, and design transfer., • Experience supporting Class III medical devices preferred. CERTIFICATIONS Preferred Qualifications • ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred., • Demonstrated knowledge of FDA Design Controls and product development processes., • Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and applicable product standards., • Experience with Design Verification, Validation, Design Reviews, Design History Files, and traceability., • Experience performing Design and Process FMEAs and applying risk management principles., • Knowledge of process validation (IQ/OQ/PQ), manufacturing process development, and design transfer., • Familiarity with supplier quality management and contract manufacturing., • Ability to interpret engineering drawings, GD&T, and product specifications., • Strong technical writing and documentation skills., • Excellent communication and collaboration skills within multidisciplinary development teams., • Ability to balance innovation with regulatory compliance in a fast-paced product development environment. Compensation The base salary range for this role is $130,000 – $150,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) *Intern positions not eligible • Subsidized medical and dental insurance coverage for you and your dependent(s), • Life insurance, short-term disability, long-term disability, • 401k, • Discretionary unlimited PTO, • Flexible Spending Account for you and your dependent(s), with eligible plan elections, • Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.

Job DescriptionDescription: Company Description Davenergy Solutions is a rapidly growing, profitable company headquartered in San Diego, CA. Our employees are the key to maintaining our competitive edge. To attract and retain the best industry talent, Davenergy Solutions shares its success with its employees and is committed to providing a professional work environment where learning, growth, and recognition are highly valued. If you are seeking an opportunity to work in a progressive organization that offers diversified challenges and excellent opportunities for advancement, we encourage you to review our current employment opportunities. For more information about Davenergy Solutions and open positions, please visit www.davenergy.com. Position Summary We are seeking a qualified Fire Protection Engineer (FPE) to support healthcare and federal facility projects for the U.S. Department of Veterans Affairs (VA) and the Department of Defense (DoD). This position is responsible for performing comprehensive fire protection and life safety (FLS) design reviews, peer reviews, and field inspections to ensure compliance with applicable federal standards, VA Technical Information Library (TIL) requirements, Unified Facilities Criteria (UFC), NFPA codes, and local life safety regulations. What You'll Do As a Fire Protection Engineer, you'll play a critical role in protecting patients, healthcare staff, and federal facilities by ensuring fire protection and life safety systems meet the highest standards of engineering excellence. Through independent technical reviews, multidisciplinary coordination, field inspections, and final compliance certifications, you'll help deliver safe, code-compliant healthcare environments for the Department of Veterans Affairs and the Department of Defense. Working closely with multidisciplinary engineering teams, you will ensure fire protection systems are effectively integrated into mechanical, electrical, plumbing (MEP), and architectural designs for complex healthcare facilities while supporting the VA throughout the design review process. Requirements: Key Responsibilities Fire Protection & Life Safety Design Reviews • Perform independent peer reviews of fire protection and life safety (FLS) design documents prepared and sealed by outside engineering firms., • Review fire protection drawings and specifications for compliance with:, • VA Technical Information Library (TIL), • Unified Facilities Criteria (UFC), • NFPA Codes and Standards, • International Building Code (IBC), • International Fire Code (IFC), • Local Authority Having Jurisdiction (AHJ) requirements, • Review stand-alone life safety upgrade designs to verify compliance with applicable VA and DoD requirements., • Ensure fire protection systems can be effectively incorporated into hospital designs alongside mechanical, electrical, plumbing, and architectural systems., • Review sprinkler system evaluations and fire distribution reports to ensure they meet Government (GVT) intent and Statements of Work (SOW) developed by the VA. VA Design Review Process • Perform formal Fire Protection and Life Safety (FLS) reviews following receipt of design review requests and associated project documentation submitted by the VA's designated representative., • Review a variety of design documents, including:, • Design narratives, • Technical specifications, • Construction drawings, • Engineering calculations, • Requests for Information (RFIs), • Other design documentation in accordance with VA Program Guide PG-18-15 and applicable A/E submittal requirements., • Conduct review milestones throughout the design process, including intermediate and final design submissions., • Perform a comprehensive backcheck of all 65% design review comments against the 100% design submission to verify all comments have been adequately addressed., • Complete a final design review confirming compliance with all applicable codes, standards, VA criteria, and project requirements., • Prepare and issue a final certification letter stating the completed design complies with the latest applicable codes, standards, VA TIL requirements, and Unified Facilities Criteria (UFC). Field Inspections & Technical Support • Conduct on-site inspections of fire protection and life safety systems during construction or post-installation., • Verify installed systems conform to approved design documents and project specifications., • Document findings and prepare detailed inspection reports for submission to the VA., • Identify design deficiencies, code conflicts, and constructability issues while providing practical recommendations for resolution., • Participate in technical meetings with project teams, clients, architects, engineers, and government representatives. Required Qualifications • Bachelor's degree in Fire Protection Engineering or a closely related engineering discipline., • Professional Engineer (PE) license in Fire Protection Engineering or another engineering discipline with significant fire protection experience., • U.S. Citizenship is required., • Minimum 5 years of fire protection engineering experience, preferably supporting federal healthcare or government facilities., • Demonstrated experience performing fire protection and life safety design reviews., • Strong knowledge of:, • VA Technical Information Library (TIL), • Unified Facilities Criteria (UFC), • VA Program Guide PG-18-15, • NFPA Codes and Standards, • NFPA 101 Life Safety Code, • International Building Code (IBC), • International Fire Code (IFC), • Experience interpreting engineering drawings, specifications, calculations, and technical reports., • Excellent written communication skills with experience preparing formal technical review comments and compliance documentation., • Ability to travel to project sites as required. Preferred Qualifications • Experience supporting Department of Veterans Affairs (VA) projects., • Experience supporting Department of Defense (DoD) projects., • Healthcare facility engineering or hospital design experience., • Experience performing independent design reviews for government clients., • Familiarity with federal design review and quality assurance processes., • NICET certifications or additional fire protection credentials are a plus., • Active security clearance or ability to obtain one is preferred. Benefits • 401(k), • Bi-Weekly 401(k) Company Contribution (3% of Salary), • Annual Profit-Sharing contribution to 401(k), • 10 Paid Federal Holidays, • Health Insurance, • Dental Insurance, • Vision Insurance, • Paid Time Off Optional Benefits • Accident Coverage, • Short Term Disability, • Term Life Insurance, • Medical Bridge, • Critical Illness Any and all job offers are contingent pending work status eligibility and passing a federal government background check.

Project Coordinator Job Duties: Accomplishes work requirements by orienting, training, assigning, scheduling, and coaching employees.Meets work standards by following production, productivity, quality,

Project Coordinator at Lightworks.Benefits: 401(k), bonus based on performance, company parties, competitive salary, employee discounts, free food & snacks, free uniforms, opportunity for advancement, paid time off, training & development.You might be a great fit for this role if:.You're naturally o

Hill International is seeking a Project Coordinator II in San Diego, California. Hill International, with more than 4,300+ professionals in over 100 offices worldwide, provides program management, project management, construction management, project management oversight, advisory, facilities managem

Level I: 0-2 Years of Experience.Provides the project manager support and assistance in scheduling meetings, documentation, updating project documents, communication and training.Assists in information collection and validations.Helps prepare status reports and presentations.Excellent oral and writt

Under general direction of a Senior Right of Way Agent, the incumbent has extensive public contact representing the Department in dealing with property owners, tenants, the public and other agencies; act as representative of property owners; may lead and direct the work of Right of Way Agents.The in

Hill International is seeking a Project Coordinator I in San Diego, California. Hill International, with more than 4,300+ professionals in over 100 offices worldwide, provides program management, project management, construction management, project management oversight, advisory, facilities manageme

A Project Coordinator supports the successful planning, execution, and completion of projects by assisting the Project Manager and project team with various tasks.Generally working under direct supervision of a Project Manager, they are instrumental in maintaining project organization, communication

Filing Deadline: Fri 8/28/2026.UC San Diego values and welcomes people from all backgrounds.If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly en