Regulatory affairs jobs in San Diego, CaliforniaCreate job alerts

Executive Director, Nonclinical Safety & Toxicology Position Overview We are seeking a distinguished scientific leader to serve as Executive Director of Nonclinical Safety and Toxicology. This individual will shape and drive the organization's preclinical safety vision across a pipeline of innovative therapeutics, ensuring that safety programs are scientifically rigorous and positioned to support regulatory milestones from early development through commercialization. The successful candidate brings board-certified expertise in toxicology, a command of global regulatory frameworks, and the leadership acumen to build and inspire high-performing teams in a dynamic biotechnology environment. Key Responsibilities Preclinical Safety Strategy Drive the design and execution of comprehensive nonclinical safety programs aligned with pipeline stage and therapeutic area needs. Provide scientific oversight on dose selection, target organ toxicity evaluation, and translational risk interpretation. Establish phase-appropriate safety packages to support first-in-human applications and subsequent regulatory filings. Regulatory Engagement & Scientific Authority Own toxicology sections of major regulatory submissions and lead scientific responses to health authority queries. Engage directly with global agencies including FDA, EMA, and PMDA on nonclinical matters. Champion adherence to GLP standards, ICH guidelines, and evolving global regulatory expectations. Study Management & External Collaborations Direct the planning, conduct, and scientific interpretation of a full spectrum of toxicology studies — including general toxicology, genetic toxicology, reproductive and developmental safety, safety pharmacology, and carcinogenicity assessments. Build and steward CRO and vendor partnerships to deliver studies on time, within budget, and to the highest quality standards. Integrate nonclinical safety findings with DMPK, bioanalytical, pathology, and translational science functions. Risk Characterization & Program Decision Support Lead nonclinical benefit-risk assessments that inform pipeline advancement decisions, first-in-human dose selection, and clinical dose escalation frameworks. Translate preclinical findings into actionable clinical risk mitigation plans and product labeling strategy. Team Leadership & Organizational Development Recruit, develop, and lead a team of toxicology professionals. Champion scientific mentorship, individual growth, and succession planning. Cultivate a culture defined by intellectual rigor, transparency, and collaborative excellence. Enterprise-Wide Partnership Collaborate closely with Clinical Development, Regulatory Affairs, CMC, Translational Medicine, and Medical Affairs to deliver integrated development strategies. Represent the nonclinical safety function on key governance and development committees. Required Qualifications • Doctoral degree (PhD) in Toxicology, Pharmacology, or a closely related discipline, • Active DABT certification or equivalent recognized board credential, • 15 or more years of industry experience in toxicology and nonclinical drug development within pharmaceutical or biotechnology organizations, • Demonstrated success leading toxicology teams and managing external research partners, • Substantial experience supporting IND/CTA filings and direct regulatory agency interactions, • Documented track record of advancing drug candidates from discovery through clinical stages, • Ability to travel domestically and internationally up to approximately 20% of the time, • Prior executive or senior leadership title (Senior Director, Executive Director, or VP) within a Toxicology or Preclinical Safety function, • Therapeutic area depth in oncology, rare disease, neurology, immunology, or similar specialty areas, • Experience contributing to an early-stage or company-building biotech environment, • Familiarity with emerging modalities such as RNA therapeutics, gene therapy, biologics, or antibody-drug conjugates Core Competencies Regulatory toxicology expertise · Translational safety · Strategic risk assessment · Scientific communication at the executive level · Cross-functional influence · People leadership and mentoring · Comfort in fast-paced, matrixed organizations

Executive Director, Clinical Development (MD) On-site in San Diego Must have an MD Overview The organization is seeking a senior physician leader with extensive experience in obesity and cardiometabolic drug development to establish and lead clinical strategy across its therapeutic pipeline. This role will provide medical and strategic direction for programs spanning early clinical research through late-stage development, with particular focus on obesity and related metabolic disorders. The Executive Director will guide the advancement of novel therapeutics by integrating clinical science, regulatory strategy, and operational execution. The successful candidate will have a proven record of leading complex clinical programs, influencing cross-functional teams, and delivering high-quality clinical data in a biotechnology or pharmaceutical environment. Key Responsibilities Clinical Strategy & Portfolio Leadership • Define and oversee clinical development strategy for obesity and metabolic disease programs across all phases of development., • Provide senior medical leadership for study design, conduct, and interpretation, including endpoints, patient populations, safety oversight, and benefit–risk evaluation., • Serve as the company’s internal medical authority for metabolic disease programs and advise executive leadership, project teams, and external partners., • Provide accountability for execution and quality of assigned clinical programs., • Oversee development of clinical protocols, amendments, and integrated development plans., • Ensure study deliverables are completed within timelines, budget, and quality expectations., • Serve as the senior medical representative in interactions with regulatory agencies for assigned programs., • Partner with Regulatory Affairs, Clinical Operations, Biostatistics, CMC, and Program Management to align development and submission strategies., • Lead medical contributions to key regulatory documents including INDs, investigator brochures, clinical study reports, and regulatory briefing materials., • Participate in regulatory meetings and health authority interactions (e.g., FDA, EMA)., • Lead collaboration across clinical operations, pharmacovigilance, translational sciences, biostatistics, and commercial teams., • Build relationships with key opinion leaders, investigators, and advisors in obesity and metabolic disease., • Medical degree (MD) required, • 10+ years of clinical development experience within the pharmaceutical or biotechnology industry, • Demonstrated experience leading clinical studies in obesity or metabolic disease, • Significant leadership experience, including oversight of teams or programs, • Track record of directing clinical programs across multiple development stages, • Strong understanding of drug development strategy, clinical operations, and planning, • Expertise in clinical data analysis and interpretation, • Familiarity with SOPs, GCP, ICH guidelines, and regulatory compliance, • Experience supporting regulatory submissions and agency interactions (IND, NDA/BLA), • Board certification in Endocrinology, Diabetes, Metabolism, or related specialty, • Experience within a clinical research or biotech operational environment, • Strategic thinking and program prioritization, • Strong cross-functional collaboration and leadership, • Effective decision-making and problem solving, • Organizational and communication skills, • Full-time position, • Competitive compensation based on experience, • Equity participation and performance bonus eligibility, • Retirement plan with employer match, • Medical, dental, and vision coverage, • Flexible spending programs, • Life insurance and employee assistance programs, • Paid time off and holidays

Number ICIMS-2026-10152 Job function Marketing Job type Full-time Location Werfen - San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 1st Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary At Werfen, marketing is more than messaging it's the engine that drives innovation, market leadership, and better outcomes for patients worldwide. We are seeking a visionary Director, Worldwide Marketing - Autoimmunity to lead the global strategy for one of the most dynamic areas in diagnostics. This is a rare opportunity to shape the future of autoimmune testing by translating cutting-edge science, emerging market insights, and customer needs into powerful product and marketing strategies that drive global impact. As a strategic leader, you will guide the global marketing and product management vision for our entire Autoimmunity portfolio working at the intersection of science, commercial strategy, and innovation. You'll partner with world-class teams across R&D, clinical, regulatory, and commercial functions while leading a high-performance marketing team around the globe. If you are a marketing leader who thrives on turning complex scientific advancements into compelling market opportunities and inspiring teams to deliver results at scale, we want to hear from you. The role is responsible for defining and support implementation of the worldwide marketing strategy and plans for the entire Autoimmunity portfolio. This includes developing short, medium, and long-term marketing strategies, defining objectives, policies, and programs for global marketing activities. The position involves planning, directing, and coordinating marketing efforts to achieve company goals and providing advice to the Vice President of Worldwide Marketing and Service on marketing matters. Responsibilities Key Accountabilities * • Directs global marketing and product management strategy for the Autoimmunity business unit to drive market growth, portfolio competitiveness, and alignment with Werfen's overall strategic objectives, • Directs global marketing and product management strategy for the Autoimmunity business unit to drive market growth, portfolio competitiveness, and alignment with Werfen's overall strategic objectives., • Directs operations of the Global Autoimmunity Marketing and Product Management teams to ensure development and execution of effective commercial strategies, product positioning, and global marketing programs., • Leads the development and management of the Autoimmunity product portfolio across the full product lifecycle, including market assessment, product concept development, launch strategy, commercialization, and lifecycle optimization., • Collaborates with R&D, Clinical Affairs, Regulatory Affairs, and Operations to support development and successful commercialization of innovative IVD solutions aligned with market needs and regulatory requirements, including IVDR., • Supports global affiliate marketing and commercial teams by ensuring availability of effective marketing tools, product training, and strategic guidance that maximize market adoption, product utilization, and customer value., • Directs global product launch planning and execution to ensure consistent messaging, effective market introduction, and successful adoption across all regions., • Continually evaluates market trends, competitive dynamics, emerging technologies, and customer needs within the IVD and autoimmune diagnostics markets to identify opportunities for innovation and portfolio expansion., • Ensures teams develop, manage, and report key marketing and business performance metrics, including revenue growth, market share, product adoption, and return on investment for marketing initiatives., • Establishes strong collaboration with global affiliates, commercial teams, and cross-functional partners to align marketing strategies with regional needs and maximize commercial effectiveness., • Engages with Key Opinion Leaders (KOLs), scientific experts, and industry stakeholders to support market insight generation, product validation, and thought leadership within the autoimmune diagnostics field., • Provides strategic recommendations to senior leadership regarding market opportunities, portfolio strategy, product development priorities, and long-term growth initiatives within the Autoimmunity business., • Continually assesses marketing processes, tools, and organizational capabilities and implements improvements to enhance effectiveness, efficiency, and global collaboration., • Performs other duties and responsibilities as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions, • Salary Range:, • Affiliate Marketing Teams: Align global strategy with regional execution and ensure local market success., • Product Management & R&D Teams: Partner to drive product development, lifecycle strategy, and market adoption., • Regulatory & Clinical Affairs: Ensure product strategies align with regulatory requirements including IVDR and global compliance standards., • PMO (Project Management Office): Collaborate on cross-functional programs and strategic initiatives., • Cross-Functional Project Teams (Workflow, Digital, Innovation): Integrate global initiatives across disciplines., • Global Service Support (GSS), MTS, and PCG Teams: Collaborate on complex customer and technical challenges., • Key Opinion Leaders (KOLs) and External Experts: Engage for strategic insight, product validation, and market leadership., • Senior Leadership: Align on global strategy, business performance, and long-term portfolio direction., • Other Strategic Business Units: Coordinate on cross-business opportunities and portfolio synergies. Skills & Capabilities: • Ability to define, communicate, and execute global marketing and product strategies aligned with business objectives and market opportunities., • Deep knowledge of the IVD industry, autoimmune diagnostics markets, and global regulatory frameworks including IVDR., • Product Development & Lifecycle Management, • Strong expertise in product development strategy, lifecycle management, and commercialization of diagnostic solutions., • Proven ability to build, inspire, and lead high-performing global teams, including talent development and leadership succession., • Expertise in market analysis, competitive intelligence, segmentation, and VOC-driven strategy development., • Demonstrated success leading complex cross-functional initiatives across global organizations., • Communication & Influence Exceptional communication and presentation skills with the ability to influence senior leaders, external stakeholders, and global teams., • Strong understanding of P&L management, investment prioritization, ROI analysis, and strategic resource allocation., • Ability to analyze scientific data, clinical publications, financial performance, and market dynamics to inform strategy., • Ability to foster innovation, continuous improvement, and organizational adaptability in a rapidly evolving diagnostics market. Min Knowledge & Experience required for the position: • Master's degree in Marketing, Business Administration, Life Sciences, or a related scientific discipline required. MBA or advanced scientific degree preferred., • 10+ years of experience in the In Vitro Diagnostics (IVD) or regulated medical device industry. Ideally, previous significant exposure to autoimmune diagnostics or related disease areas., • Proven global marketing leadership experience, including management of high-performing teams and complex international organizations., • Demonstrated success in strategic marketing, product portfolio management, and commercialization in global markets., • Experience leading product development initiatives and managing full product life-cycle processes, from concept and development through launch and life-cycle management., • Strong understanding of IVD regulatory environments including IVDR and other global regulatory frameworks., • Track record of driving cross-functional collaboration across R&D, regulatory, clinical, operations, and commercial teams., • Experience working with Key Opinion Leaders and scientific communities within the autoimmune diagnostics space. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Salary ranges depending on skills and education and experience $210K-$250K plus bonus potential. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID:26-08555 Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: • Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable)., • Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions., • Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules., • Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts., • Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle., • Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively., • Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed., • Foster a collaborative, innovative, and compliant culture within program teams., • Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management., • Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action., • Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals, • Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required., • Ensure compliance with quality management systems and regulatory requirements, where applicable., • Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data., • Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines, • Drive design control discipline throughout product development, ensuring compliance, • Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance., • Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification., • Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing., • Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification., • Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.)., • Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs., • Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target Key Requirements and Technology Experience: • Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent., • 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment., • Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval)., • Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR)., • Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software., • Project Management Professional (PMP) certification not required but is preferred, • Scrum Master and SAFE Agile certification is preferred., • Experience in medical device industries required, including experience in FDA or other regulated environments., • Knowledge of the medical device industries beneficial integrating science and technology into business processes., • Technical background in electrical, mechanical, or biomedical engineering, • Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones., • Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines, • Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures., • Drive for accountability within self and others., • Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations, • Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements., • Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality., • Direct experience with major test labs and certification bodies for medical electrical equipment standards., • Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus), • Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification., • Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements., • Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations. Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy ___.

Number ICIMS-2025-8921 Job function Marketing Job type Full-time Location Werfen - San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 1st Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary The Clinical Scientific Manager (CSM) fulfills two key functions within the Strategic Business Unit (SBU) for Autoimmunity in San Diego. The CSM plays are key role as Autoimmunity's scientific subject matter expert by representing the company at a worldwide level and assisting in identifying, developing and maintaining relationships with international key medical experts and opinion leaders, as well as support of scientific studies. This position plays a crucial role in promoting scientific understanding of our assays and developing content to promote their value to our customers. In addition, the CSM is responsible for coordinating internal resources to drive resolution to complex customer product investigations, resolve technical issues not related to complaints to achieve affiliate and customer satisfaction, and interfacing within and outside Werfen, including responsibility for effective technical communications, reporting, and presentations. Responsibilities Key Accountabilities • Scientific Education Strategy: Develop and execute comprehensive scientific education strategies and programs. Collaborate within the SBU Marketing team to align the education initiatives with business objectives. The CSM will develop a customer focused educational campaign focused on existing Werfen products or products in development, to be executed with commercial teams. The CSM will also create content for the internal Werfen Autoimmunity teams to ensure that they understand basic concepts and stay up to date regarding new scientific developments., • Material Creation: Ensure effective and engaging clinical materials, presentations, and resources for Werfen employees and external stakeholders to enhance understanding of Autoimmunity solutions and their clinical applications. The CSM will create clinical material to support customer facing applications and commercial teams to enhance their understanding of autoimmunity in order to effectively support customers., • External Workshops and Seminars: Support scientific workshops, webinars, seminars, and symposia for healthcare professionals, researchers, and key opinion leaders to promote awareness and knowledge of Autoimmunity solutions. The CSM will work with key opinion leaders and topic specific experts to create content for presentations. The CSM will also directly present topics related to autoimmunity in these forums., • Key Opinion Leader (KOL) Networking & Engagement: Build and maintain relationships with key opinion leaders and renowned scientists. Collaborate on research initiatives and seek insights to enhance product development and education strategies. The CSM will communicate with KOLs to engage with Werfen as scientific advisors to educate Werfen Marketing and R&D on topics related to product development and to share their vision for the future. This communication can take the form of regular communication with KOLs or organized meetings with several KOLs for this purpose., • Clinical On-market Escalated Support: support escalated investigations for key Werfen stakeholders (affiliates and customers, when applicable) in managing inconclusive or seemingly unsupported clinical scientific outcomes, including from external quality programs. The CSM will review escalated complaints with a cross-functional team on a regular basis, direct internal investigations and communicate status and outcomes (written or live) with global affilates and customers, • Commercial Partnership: Assist Marketing and Affiliate teams in clinical discussions and presentations with potential clients, healthcare professionals, and laboratory personnel. Provide scientific expertise and address queries to facilitate successful commercial efforts. The CSM will often participate in direct discussions or meetings with laboratorians and clinicians to provide expertise and guidance related to clinical or product focused topics., • Clinical Market Intelligence: Stay abreast of the latest advancements and research developments, including from competition. Analyze clinical and scientific trends to ensure the company remains at the forefront of scientific innovation., • Increase clinical awareness of Autoimmunity diseases and the importance of accurate and timely patient diagnosis. CSM may work directly with patient advocasy groups as well as specific clinical autoimmunity initiatives globally., • Evaluate, at an international level, the clinical guidelines related to our products and solutions and help to spread them throughout the company, both among the Technology Center and affiliates. CSM will regulary review evolving international guidelines for diagnosis and treatment of autoimmune diseases and become involved in guidleine committees when possible., • Comply with applicable standard operating procedures (SOPs), ISO, FDA and other applicable Quality System regulations, as well as with applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies. Networking/Key relationships This position requires extensive collaboration and partnership with teams: • Marketing & Global Systems Support, • Product Complaints Group, • R&D teams, including Manufacturing Technical Support (MTS), • Regulatory Affairs, • Manufacturing, Operations & Logistics, • Global Affiliates & Distributors Minimum Knowledge & Experience required for the position Education • Previous experience of at least 5 years in Marketing Department/Clinical Affairs in a multinational company required, preferably in the IVD or Medical Device industry. Advanced experience and demonstrated business acumen, agility, and confidence in making decisions required., • Alternatively, at least 5 years of experience as an Immunology Supervisor (or higher) in a large healthcare system, • Advanced experience and demonstrated indirect leadership of cross-functional teams within organizations required., • Successful track record of customer facing interactions with a strong technical background in ELISA, IFA, CIA, and PMAT., • Knowledge of immunology and immunoassay technology, particularly with Autoimmune diagnos-tics methodologies., • Knowledge of the clinical lab environment, ideally with in vitro diagnostics, • Strong background in scientific education, training, and communication strategies., • Knowledge of relevant regulations and compliance standards governing the IVD industry (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, ISO 17025, IEC 60825 or other regulations and standards)., • Exceptional presentation, communication, and emotional intelligence skills, with the ability to convey complex scientific concepts to diverse audiences., • Ability to adapt to an evolving business and industry, leveraging previous knowledge, interper-sonal skills, project management skills and self-motivation., • Proven track record independently producing quality and timely work in a fast-paced environ-ment with demonstrated agility, resilience, and initiative., • Comfortable working in under multiple deadlines and priorities. Travel requirements:Up to 30%, may include international travel and/or travel on short notice. Work Environment: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. Other Duties and Acknowledgement: The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen. The annual base salary range for this role is currently $150,000 range to $210,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

East Campus Medical Center (Alvarado Road) 6655 Alvarado Road, San Diego, CA 92120, United States Filing Deadline: Wed 4/8/2026 ___ 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 encourage you to apply. UCSD Layoff from Career Appointment: Apply by 3/30/2026 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Reassignment Applicants: Eligible Reassignment clients should contact their Disability Counselor for assistance. This Inpatient Rehab Manager position will provide direct supervision to therapy staff including but not limited to Physical, Occupational and Speech Therapists, as well as Rehab Aides for inpatient services based at the East Campus. Responsibilities include but not limited to: maintaining departmental efficiency, productivity and performance, hiring and staffing, and resolution of daily clinical program and operational issues. The Inpatient Manager will be responsible for leading the inpatient team to meet organizational goals, exemplifying UC San Diego Health core values, and supporting efforts to provide outstanding patient care and customer service. The manager position requires a weekend on-call manager schedule. The provision of patient care is at times required. * Bachelor's degree from an accredited school of Physical, Occupational or Speech Therapy. * Licensed in related Rehabilitation Service. * BART or BLS at time of hire with commitment to get BART within six months of hire date * Five (5) or more years experience working as a Physical, Occupational or Speech Therapist. experience. * Minimum one year managerial experience in an acute inpatient therapy department. * Prior experience leading meetings, managing departmental scheduling, and participating in regulatory affairs. • Master's or Doctorate degree in Physical, Occupational or Speech Therapy., • Experience in Process Improvement (Lean/Six Sigma)., • Must be able to work various hours and locations based on business needs. Annual Full Pay Range: $108,100 - $204,900 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $51.77 - $98.13 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, the only Burn Center in the county, and dozens of outpatient clinics. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit ___. The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. For the University of California's Anti-Discrimination Policy, please visit: ___ UC San Diego is a smoke and tobacco free environment. Please visit ___ for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening. Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

He/She will be responsible for representing regulatory function to approve promotional material.

The Senior Manager of Regulatory Affairs will be based in San Diego, CA and will provide regulatory support for the Dispensing Platform.

ResponsibilitiesCollaborate cross-functionally with Clinical Development, Manufacturing, Regulatory Affairs, and Quality Assurance to plan and execute IMP supply planning including labeling and packaging, utilization forecasting, inventory control, and international shipments and external depot mana

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 diseases 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: Senior Project Manager Location: Onsite - San Diego, CA Job Overview: We are seeking a highly motivated and experienced Senior Project Manager to lead and support cross-functional projects within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will be responsible for managing projects from early development through launch, ensuring project goals, timelines, and budgets are met while maintaining alignment with company strategy and regulatory requirements. The ideal candidate will bring strong project management skills, a solid understanding of the biotech or medical device industry, and the ability to drive results through leadership, organization, and effective communication. Key Responsibilities: • Manage cross-functional project teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial functions to deliver IVD/diagnostic products from feasibility through commercialization., • Develop and maintain comprehensive project plans, schedules, and budgets, tracking milestones, dependencies, and deliverables., • Monitor and report on project status, risks, and issues, providing clear updates to project stakeholders and senior leadership., • Coordinate resources and align priorities across internal departments to support timely and efficient project execution., • Support regulatory submission readiness activities, ensuring projects comply with applicable regulatory and quality standards (e.g., FDA, ISO 13485)., • Facilitate regular project meetings, including team updates, risk reviews, and issue resolution sessions., • Assist in managing external vendors and partners involved in development, manufacturing, or other project-related activities., • Contribute to continuous improvement initiatives in project management processes, tools, and methodologies. Qualifications: • Bachelor’s degree in Life Sciences, Engineering, Business, or a related field; advanced degree (MS, MBA) preferred., • 5-8 years of project management experience in the biotech, diagnostics, or medical device industry, with a focus on product development in a regulated environment., • Solid understanding of regulatory pathways, quality systems (e.g., ISO 13485), and product commercialization processes for IVDs or medical devices., • Proven ability to manage cross-functional project teams and deliver projects on time and within budget., • Life Science/IVD industry experience highly preferred., • PMP certification or formal training in project management strongly preferred., • Excellent organizational, leadership, and interpersonal skills., • Experience supporting global product launches and managing distributed or cross-site teams., • Familiarity with project management software and tools., • Exposure to Agile or Stage-Gate development methodologies., • Strong problem-solving, critical thinking, and decision-making abilities., • 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 ABOUT GENALYTE At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities. POSITION SUMMARY Genalyte, Inc. is seeking a highly skilled and motivated Regulatory Affairs Specialist to join our dynamic team. In this pivotal role, you will leverage your expertise to navigate regulatory landscapes, ensuring our groundbreaking products meet all regulatory requirements and reach the market efficiently. If you are passionate about advancing healthcare through cutting-edge technology and thrive in a collaborative environment, we invite you to be a part of our mission to transform diagnostic testing and improve patient outcomes. The Regulatory Affairs Specialist will assist in defining and executing regulatory strategies, preparing regulatory submissions, interpreting regulations, performing regulatory research, and providing regulatory guidance throughout the product lifecycle. This role will be responsible for preparing submission documents and work cross functionally with other departments to ensure timely completion of deliverables related to regulatory submissions. Supports interactions with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVD/IVDD, CFR and other regulatory requirements. ESSENTIAL FUNCTIONS & RESPONSIBILITIES These may include but are not limited to: • Develop and implement regulatory strategies for new IVD products, significant design changes, and sustaining projects to achieve timely market access in target regions, • Collaborate with Quality, Clinical, R&D, Manufacturing, and Commercial teams to align on regulatory objectives, communicate regulatory requirements, and track submission deliverables according to project timelines, • Draft, review, and refine technical documents for regulatory submissions, ensuring alignment with applicable guidance, • Coordinate and manage pre-submissions for prompt FDA responses and feedback, • Support the preparation and submission process for 510(k), PMA, and CE applications, • Oversee the e-STAR regulatory documentation requirements to meet FDA submission standards, • Monitor evolving global IVD regulations (FDA guidances, IVDR updates, harmonization efforts) and assess impact on products/portfolio; develop and implement compliance plans, • Support post-market activities, including vigilance reporting, corrections and removals, field safety corrective actions (FSCA/FSC), periodic safety update reports, and post-market surveillance/performance follow-up, • Support the development, review, and approval of labeling, promotional materials, and marketing claims for regulatory compliance, • Monitor, maintain, and ensure the accuracy of regulatory registrations, certifications, and licenses, • Support external regulatory agency audits, offering regulatory insights to prevent non-compliance issues, • Organize and maintain all regulatory-related documentation meticulously, • Support maintenance and improvement of the company’s Quality Management System (QMS), • Support the internal audit program as requested, • Perform additional duties as assigned, contributing to the team's success EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES: • A minimum of a Bachelor’s degree in Science or related discipline of 3 years experience in IVD regulatory affairs or equivalent, • Experience working in a FDA QMSR and ISO 13485 environment, • Certification in regulatory affairs is a bonus, • Excellent understanding of regulations, consensus standards, guidances, and public databases relevant to regulatory research and guidance, • Strong analytical and problem-solving skills, • Excellent written and Verbal communication skills with the ability to listen, articulate and advocate, • Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines, • Must possess a high degree of accuracy and attention to detail, • Ability to communicate effectively with employees across multiple departments, • Ability to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations, • Proficient in Google and Microsoft Office applications - Google Docs, Sheets, Slides; Microsoft Word, Excel, and Powerpoint a3X7oBsc0S

Job DescriptionCompany Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to , and follow us on X or LinkedIn. The Director, IT Enterprise Applications is responsible for the strategic leadership, implementation, and ongoing optimization of ORIC’s enterprise applications ecosystem. This role ensures that core business systems—spanning ERP, Finance, Procurement, Travel & Expense, Supply Chain, and regulated GxP platforms—are scalable, compliant, and operationally robust as ORIC advances from clinical development into commercialization. This leader brings deep hands-on experience with cloud ERP platforms (preferably NetSuite) and adjacent systems such as Coupa, Expensify, and Navan, along with proven ownership of validated GxP systems, including Veeva Vault, SAS, and DocuSign (Part 11). The role partners closely with Finance, Quality, Supply Chain, Clinical, and Commercial teams to enable compliant growth, strong controls, and data-driven decision‑making. This hybrid role is based out of either our South San Francisco, CA or San Diego, CA office Job Description Enterprise Applications Strategy & Governance • Define and execute a multi-year enterprise applications roadmap aligned with ORIC’s clinical and commercial growth strategy., • Serve as system owner for ERP, procurement, T&E, contract management, and related enterprise platforms., • Establish and enforce application governance, including SDLC, validation, change management, release management, and documentation standards., • Own the end-to-end lifecycle of ORIC’s ERP platform (strong preference for NetSuite), from design and implementation through optimization and support., • Act as system owner for Coupa (Procurement), Expensify, and Navan, ensuring seamless integration with Finance and Operations workflows., • Partner closely with Finance to maintain SOX-compliant IT General Controls (ITGCs), audit readiness, and financial reporting integrity., • Partner with Quality, Regulatory, Clinical, and Medical Affairs to support validated systems and compliant processes., • Oversee IT ownership and support of regulated platforms, including:, • Veeva Vault (Quality Docs, QMS, RIM, etc.), • SAS (clinical and statistical platforms), • DocuSign with 21 CFR Part 11–compliant workflows, • Ensure enterprise systems meet GxP, 21 CFR Part 11, data integrity, and GDPR requirements., • Lead and develop a high-performing enterprise applications team, including internal staff and external consultants., • Own vendor relationships, implementation partners, and Statements of Work (SOWs)., • Drive application portfolio cost optimization, licensing strategy, and ROI., • Establish and track KPIs for system availability, support SLAs, delivery quality, and continuous improvement.Qualifications Required • 12+ years of progressive experience in enterprise applications and IT leadership roles., • Deep hands-on experience implementing and supporting cloud-based ERP systems (NetSuite strongly preferred)., • Demonstrated ownership of GxP‑validated systems and validation initiatives., • Strong understanding of SOX ITGCs, audit processes, and financial systems controls., • Experience integrating supply chain systems and managing 3PL connectivity., • Proven ability to lead complex, cross-functional enterprise system implementations in a regulated environment., • Direct administration experience with:, • Coupa, • Expensify, • Navan, • Commercial‑stage biotech systems exposure (CRM, distribution, chargebacks, gross‑to‑net)., • Familiarity with enterprise integration architectures and iPaaS platforms., • PMP, ITIL, or other relevant certifications. Additional Information The anticipated salary range for candidates who will work on-site at our San Diego location is between $220,000-$240,000 and South San Francisco is between $240,000-$260,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

Job DescriptionThe Vice President of Global Medical Affairs will provide strategic and hands-on leadership for Janux. Therapeutics. This role will be highly external-facing and execution-driven, responsible for shaping scientific narrative, building key external relationships, and ensuring high-quality, compliant medical engagement as Janux advances its clinical-stage oncology programs. The VP, Medical Affairs will report directly to the Chief Medical Officer, and partner closely with Clinical Development, Regulatory, Translational Science, and Commercial colleagues to ensure strong alignment between clinical strategy, external scientific exchange, and future commercialization readiness.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Build, lead, and execute the overall Medical Affairs strategy in alignment with Janux’s clinical development and corporate objectives., • Establish scalable, compliant Medical Affairs infrastructure, processes, budgets, and operating models appropriate for a growing clinical-stage biotech organization., • Serve as a key member of the cross-functional leadership team, providing medical and scientific insight to inform development and business decisions., • Develop and oversee scientific and medical communications, including publications, congress strategy, scientific presentations, and medical information content., • Shape and refine the clinical and scientific value across Janux’s oncology pipeline to ensure clear, accurate, and compelling external communication., • Ensure consistency and scientific rigor across all external-facing medical materials and engagements., • Build and maintain strong relationships with leading investigators, key opinion leaders, and other external experts in oncology and immunotherapy., • Lead the planning and execution of advisory boards, investigator meetings, and scientific exchange activities., • Represent Janux at major national and international scientific congresses and meetings through direct engagement and presentations., • Partner closely with Clinical Development, Clinical Operations and Translational teams to provide medical input into protocol design, endpoint selection, and evidence generation strategies., • Collaborate with Regulatory Affairs to ensure compliant scientific exchange and alignment with global regulatory standards., • Support commercialization readiness by providing medical expertise for internal training, external education, and payer‑relevant evidence strategies., • Demonstrated knowledge of implementing tools to optimize and expand reach and frequency of interactions with US providers, advocacy organizations, patients, and key partners., • Direct knowledge of promotional regulatory processes, Fair Market Value (FMV) process, tiering, and alignment with third-party vendors., • Ensure all Medical Affairs activities are conducted in accordance with FDA, ICH, and other applicable regulatory and compliance guidelines., • Establish and maintain high-integrity processes for HCP and KOL interactions, publications, and scientific exchange., • Available to travel and work independently as well as with other senior executives.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS, AND ABILITIES, • Advanced degree required (MD, DO, PharmD, PhD, MS or equivalent)., • 15+ years (20 years preferred) of experience in Global Medical Affairs within biotech and/or pharmaceutical organizations, with increasing leadership responsibility., • Significant experience in oncology required, including experience with immuno-oncology, cell therapy, or novel biologic platforms like T cell engagers., • Demonstrated success in building and leading Global Medical Affairs functions in clinical-stage or emerging biotech environments., • Proven track record in KOL engagement, scientific communications, and cross-functional collaboration., • Strong understanding of Medical Affairs compliance, scientific standards, and regulatory requirements.

Job Description The Vice President of Quality will establish, lead and develop the quality function, in line with the company’s stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment. Key Responsibilities: • Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical and nonclinical studies, PV vendors, and CROs, • Maintain efficient systems and processes that ensure Contineum and its vendor network comply with GXP standards, • Ensure the appropriate identification, evaluation, and management of risks associated with quality, • Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment., • Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations, • Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle, • Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and external teams to implement corrective and preventive actions, • Lead the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation, • Create and implement risk-based quality strategies that identify and address potential quality risks, • Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues, • Ensuring vendors adhere to relevant quality programs, regulations, and guidelines, and preparing them for regulatory inspections, • Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP and PV activities, • Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations, • Stay updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global GXP/PV regulations and guidance, • Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities, • BS/BA in biology or related Life Sciences discipline, or equivalent experience, • Minimum of 15 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development, • Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines, • Expertise in Quality Management Systems (QMS), • Extensive knowledge of quality risk assessment and management methodologies, with a successful track record in their application and risk mitigation, • Proven experience in establishing and managing a quality organization and GXP and CSV experienced team members, • Track record of success in a biotech start-up or fast-paced, innovative, dynamic environment, with the ability to remain flexible, proactive, resourceful, and efficient, • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment, • Strong management, interpersonal, and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff, • Demonstrated ability to lead and motivate cross-functional teams, • Willingness and desire to “roll up your sleeves” and perform activities and responsibilities to support the team We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $300,000- $350,000. 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, etc. Contineum offers competitive compensation and benefits, including: • 90% employer-covered benefits, • Flexible PTO, • A very generous holiday schedule that includes a week off in August and time off around the winter holidays, • A well-stocked kitchen with snacks and beverages, • Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match., • The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director, Regulatory Operations, is responsible for strategic and operational leadership of complex submissions, publishing, and regulatory information management systems. This role ensures the delivery of high-quality, compliant regulatory dossiers. This role ensures the delivery of high-quality, compliant regulatory dossier to FDA and global health authorities. The Associate Director serves as a subject matter expert in electronic submissions (eCTD), publishing systems, and regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization. Responsibilities • Provide operational leadership and oversight for global regulatory submissions, ensuring compliance with applicable regional regulations and technical requirements. Oversee preparation, publishing, quality control, and transmission of electronic submissions (eCTD) for INDs, NDAs, CTAs, MAAs, and post-approval submissions, • Ensure submissions deliverables meet health authority formatting, validation, and technical standards, • Own and oversee regulatory publishing systems and regulatory information management systems (e.g., Veeva RIM), ensuring system integrity, compliance, and optimization., • Establish and maintain standardized processes for document formatting, publishing workflows, submission validation, and archiving., • Oversee regulatory archiving and document retention practices in accordance with global regulatory requirements., • Evaluate and implement system enhancements, automation, and emerging technologies to improve efficiency and compliance., • Develop and maintain SOPs and work instructions related to regulatory operations and publishing., • Serve as the regulatory operations expert to advise teams on submission standards, timelines for technical preparation, and health authority expectations., • Partner closely with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners/vendors to ensure clarify of submissions requirements and operational readiness., • Perform quality control checks and work with the subject matter expert to address findings, • Identify and resolve formatting, technical, and compliance issues related to publishing manners in collaboration with subject matter experts, • Bachelor's degree in life sciences, computer science, or related science discipline, • 8+ years of relevant experience in pharmaceutical, biotechnology, or life sciences industry, including leadership experience in Regulatory Affairs Operations and Publishing, • Deep expertise in electronic submission requirements (eCTD and regional variations), • Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools), • Experience preparing and publishing high-quality electronic regulatory dossiers with major health authorities, • Demonstrated understanding of regulatory systems from both business process and end-user perspectives., • Experience with regulatory information management systems (e.g., Veeva RIM)., • Knowledgeable in emerging technologies, including AI applications in regulatory operations., • Ability to serve as senior publishing SME and technical escalation point All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Senior Director, Quality Assurance & Quality Systems provides strategic and operational leadership for all quality activities supporting Capricor’s clinical-stage and advancing commercial-stage organization. This role has full accountability for the design, execution, and continuous improvement of the Quality Management System (QMS) to ensure sustained regulatory compliance, inspection readiness, and robust quality oversight across development, manufacturing (including cell therapy production), and potential commercialization of Deramiocel and StealthX™-based programs. The Senior Director partners closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to enable late-stage development, BLA submissions and responses (including addressing any quality-related aspects of the Deramiocel pathway), commercial readiness, and scalable growth while embedding a proactive, risk-based quality culture across the enterprise.Responsibilities • Define and execute the enterprise quality strategy aligned with late-stage clinical development, BLA/regulatory submissions, potential commercial launch, and post-approval lifecycle management for cell and exosome-based therapies., • Serve as the senior Quality leader and strategic advisor to executive and operations management on compliance matters, inspection readiness, quality risk management, and GxP expectations in a biotech environment., • Own and continuously enhance the enterprise QMS to support clinical, manufacturing, and commercial operations, including Document Control and Change Management, Deviations/Investigations/CAPA, Training and Qualification, Data Integrity and Records Management, and other core quality processes., • Ensure quality systems are phase-appropriate, scalable, efficient, and fully aligned with FDA GMP regulations (21 CFR Parts 210/211, 820, and biologics-specific guidance), ICH guidelines, ISO standards, and global expectations for advanced therapies., • Ensure ongoing compliance with FDA, GMP, and applicable global regulations for clinical trials, manufacturing, and potential commercial activities, including cell therapy and exosome platforms., • Lead preparation for, management of, and response to regulatory inspections (including PAIs), partner audits, and health authority interactions; act as the primary Quality representative during agency engagements and inspections., • Provide comprehensive quality oversight for clinical quality assurance, including GCP compliance and support for ongoing trials such as HOPE-3 extensions or related activities., • Oversee quality support for manufacturing, testing, process validation, technology transfer, comparability studies, and supply chain activities for late-stage and commercial products (e.g., Deramiocel cell therapy production)., • Ensure timely and effective resolution of quality events, deviations, CAPAs, complaints, and out-of-specification results, with appropriate escalation, root cause analysis, and management visibility., • Collaborate closely with Clinical, Regulatory Affairs, CMC/Process Development, Manufacturing, Supply Chain, Quality Control, and Commercial teams to integrate quality principles throughout the product lifecycle and enable efficient, compliant decision-making., • Establish, monitor, and report quality KPIs, trends, risk indicators, and compliance metrics to senior leadership and the Quality Management Review., • Drive continuous improvement initiatives, including process optimizations, lessons learned from inspections/audits, and enhancements to strengthen compliance maturity, operational efficiency, and inspection outcomes., • Build, lead, and mentor a high-performing QA and Quality Systems organization; develop talent, succession plans, and training programs to support organizational scaling and commercialization milestones., • Foster a collaborative, accountable, and inspection-ready mindset across the quality team and broader company.Requirements, • Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred., • 12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments, with significant focus on biologics, cell therapies, or advanced therapy medicinal products., • 7+ years of senior leadership experience with direct ownership and oversight of enterprise Quality Management Systems in a growing organization., • Hands-on experience supporting late-stage clinical programs, BLA submissions, pre-approval inspections (PAIs), and commercial readiness/launch activities for regenerative medicine or biologics products., • Deep knowledge of FDA regulations (including 21 CFR Parts 210/211, 820, biologics-specific guidance), GMP, ICH guidelines (Q8-Q12, etc.), and global standards relevant to cell and exosome therapies., • Demonstrated success leading regulatory inspections (PAIs, routine GMP inspections), responding to findings, and maintaining inspection readiness in dynamic settings., • Proven ability to scale QMS and quality organizations in a rapidly growing biotech company preparing for commercialization., • Strong executive presence with the ability to influence, collaborate with, and advise cross-functional teams and senior leadership., • Excellent communication, problem-solving, decision-making, and strategic thinking skills.Work Environment / Physical Demands, • Office-based with routine presence in GMP manufacturing and laboratory environments to support oversight, audits, inspections, and quality activities., • Extended periods of computer use for documentation review, data analysis, metrics reporting, and quality system management., • Occasional lifting of office or light materials up to 10 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. Education: • Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required., • 5–7 years of regulatory affairs experience within the medical device or IVD industry., • Working knowledge of 510(k) submissions and regulatory documentation processes., • 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., • 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 DescriptionThe Director, Global Regulatory Affairs will play a critical role in developing and implementing regulatory strategies to support the global development and expansion of Janux’s clinical pipeline. This player-coach individual will work closely with cross-functional teams to ensure compliance with regulatory requirements and to achieve successful regulatory approvals.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Develop and execute global regulatory strategies for one or more programs., • Will be the regulatory lead for project teams and sub-teams for one or more programs., • Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs, MAAs, etc.)., • Serve as the primary regulatory contact with health authorities, including the FDA, EMA, MHRA and other global regulatory agencies for assigned programs., • Provide regulatory guidance and support to cross-functional teams, including Clinical, Therapeutic Discovery, and CMC teams., • Monitor and interpret regulatory requirements and trends to ensure compliance and to inform strategic planning., • Manage regulatory timelines and ensure timely submission of regulatory documents., • Lead regulatory agency meetings and negotiations., • Own the preparation of regulatory documents, including briefing packages, responses to health authority queries, and labeling., • Ensure that all regulatory activities are conducted in accordance with applicable regulations, guidelines, and company policies., • Other duties as deemed necessary., • Travel up to 25%EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • BS degree in life sciences or a related field is required. Advanced degree in life sciences (MS, PhD, PharmD, MD, or equivalent) preferred., • Minimum of 10 years of experience in regulatory affairs within the biotechnology and biopharmaceutical industries and working knowledge of the development of biologics targeted for the treatment of cancer., • Proven track record of successful regulatory submissions and approvals, alongside successful direct interaction with global regulatory agencies (FDA, EMA MHRA and others)., • In-depth knowledge of global regulatory requirements and guidelines is required., • Strong leadership and project management skills., • Excellent written and verbal communication skills., • Ability to work effectively in a fast-paced, dynamic environment., • Strong analytical and problem-solving abilities.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor’s product lifecycle, with primary accountability for Deramiocel’s BLA pathway and advancement of other pipeline candidates from development through potential commercial approval and post-approval maintenance. Reporting to and collaborating closely with the VP of Regulatory Affairs, this role develops and executes CMC regulatory strategy, ensures compliance with global requirements (FDA, ICH, EMA), identifies and mitigates risks, and partners with cross-functional teams (CMC Development, Manufacturing, Quality, MSAT, Supply Chain, and others) to drive successful submissions, health authority interactions, and company objectives in a fast-paced, mission-driven biotech environment.Responsibilities • Develop, own, and execute CMC regulatory strategy across the product lifecycle (from development through commercial and post-approval phases) in alignment with global regulatory requirements and Capricor’s overall regulatory and business goals., • Oversee and lead the preparation, authoring, review, final approval, compilation, and submission of CMC sections for major regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, MAAs, responses to queries/information requests, and post-approval changes)., • Proactively identify risks related to documentation, content, quality, or timelines for global CMC submissions; collaborate with Manufacturing, Quality, Process Development, MSAT, and other departments to ensure timely delivery of approved, high-quality technical source documents., • Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, process validation summaries, comparability protocols, and deviation/investigation reports., • Foster CMC regulatory alignment and phase-appropriate readiness by collaborating with supporting departments (Manufacturing, Quality Assurance, MSAT, Supply Chain, Commercial, etc.) to support development, scale-up, validation, and commercial readiness activities., • Review and approve product labeling with responsibility for CMC-related claims, product descriptions, manufacturing statements, and participate in Advertising & Promotion review committees as needed., • Manage, mentor, and develop regulatory affairs professionals; provide leadership, oversight, accountability, and support to ensure high-performance deliverables and team growth., • Serve as the primary CMC interface with health authorities (primarily FDA for biologics/cell therapies, potentially EMA) for submissions, negotiations, formal meetings (e.g., Type meetings, pre-BLA interactions), and responses to queries or deficiencies (including addressing any CMC-related items from the Deramiocel CRL)., • Monitor global regulatory trends, guidelines, and precedents (e.g., ICH Q updates, FDA guidance on CMC for cellular/gene therapies, advanced therapies) and adapt Capricor’s CMC strategies proactively to maintain compliance and competitive advantage., • Contribute to regulatory risk assessments, gap analyses, contingency planning, and inspection readiness for CMC aspects and manufacturing sites., • Perform such other duties as may be assigned from time to time.Requirements, • Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) preferred., • 8+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, including significant experience with biologics, cell therapies, or regenerative medicine products; commercial-stage product experience (post-approval lifecycle management) highly preferred., • Proven track record of preparing, authoring, leading, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including successful responses to agency queries, deficiencies, or Complete Response Letters., • In-depth knowledge of global regulatory requirements and guidelines relevant to CMC for biologics and cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, process validation, stability, comparability, potency assays)., • Experience supporting BLA or similar submissions for advanced therapy products, with familiarity in addressing CMC issues in late-stage reviews or post-CRL scenarios preferred., • Strong project management skills with the ability to lead multiple complex projects, manage timelines, resources, and cross-functional dependencies in a dynamic environment., • Exceptional communication skills (written and verbal) for effective interaction with internal teams, external partners, and health authorities, including authoring clear regulatory documents and presenting strategies., • Proficiency in regulatory information management systems and tools (e.g., Veeva RIM, document authoring/publishing software)., • Demonstrated leadership abilities, including mentoring and developing team members, fostering collaboration, and driving accountability., • Ability to work strategically and independently while thriving in a collaborative, fast-paced setting.Work Environment / Physical Demands, • Primarily office-based with tasks involving regulatory documentation, strategy development, and cross-functional/global coordination., • Requires prolonged periods of computer use for drafting, reviewing, compiling, and reporting on CMC documents and submissions., • May involve lifting office materials up to 15 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Job Title: Safety and Regulatory Quality Control - V Location: Southern CA in 92037 / Remote Duration: 15 months Description: Role Description: • The Contractor Quality & Regulatory Lead (CQRL) actively contributes as part of the ESOQ Tier 2 structure to ensure that Client network of External suppliers/CMOs /partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/applicable GMP/GDP regulations., • The CQRL is also the liaison between the site and Global Regulatory Science (GRS), which works collaboratively with Contract Manufacturing Organizations (CMOs), Virtual Site Operating Teams (VSOTs), and Regulatory colleagues to determine when the Regulatory Change Management Process is required. Responsibilities: • Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/product(s) to Client according to established procedures., • Provide Quality Leadership and act as regulatory expert within the VSOT, advising of regulatory strategy and potential supply constraints, if any., • Assess the quality of external supplier’s products, processes and related documents while ensuring the product specifications are met and quality systems are maintained., • Support internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors, including RQA audits or regulatory inspections, as applicable., • Support internal and external partners with Compliance Assessments to ensure current CMP/GDP adherence., • Support onboarding activities of new CMOs or product launches within the portfolio as applicable., • Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Client requirements., • Influence quality decision making in line with industry and Client requirements, • Partner with colleagues to develop and negotiate Quality Agreements., • Review and approve Annual Product Review and Product Quality Review (APR/PQR) reports and relevant product stability reports., • On time endorsement of Product., • Support Post-Approval Changes, initial registrations and/or renewals., • Review & assess the changes affecting ESOQ managed CMOs by performing regulatory impact assessment in collaboration with Regulatory Strategists as needed., • Assume ownership of changes as described in associated change control procedures and processes to ensure timely progression of activities to support change completion., • Act as a liaison between CMOs, VSOTs, PGS sites within the Global CMC organization, Regional Strategist (if required) or Client Country Offices (PCO), • Raise Change Management eQMS records, facilitate PAC creation and discussion within the VSOT and open regulatory Product Change Form (PCF) for CMO or Client-initiate Poast Approval Changes with potential regulatory impact., • Coordinate the collection of supporting documents for Post-Approval Changes, initial registration, renewals, and BoH queries from CMOs (ESOQ CRL) and PGS sites (PGS SCNM) as required., • Monitor and notify the CMO and VSOT through the escalation process of regulatory submission status, BOH queries, commitments, and approvals., • Act as regulatory expert for CMO liaising with Client GRS and supporting systems (e.g., RRM, PEARL, GDMS, etc.), • Support in Dossier Compliance Assessment and New Regulations/Compendia requirements implementation as required and involve the CQL appropriately., • Actively contribute to QRTs and support on site investigation, regulatory discrepancies and any other relevant activity impacting QRTs decisions., • May Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards., • Ensure the adequate tracking and documentation of all required quality related actions in the relevant system(s) and that all required escalation processes are followed., • Lead and support complex investigations, market complaints, risk assessments in support of products within your portfolio. Connect with SMEs where needed., • Support Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal products., • Work independently, receive instructions primarily on unusual or complex problems., • Build, maintain and develop relationships with key stakeholders, both internal and external to Client., • Support ESOQ leadership in other tasks & projects as required., • Support the management of Expedited Product Quality Complaints. Regulatory Change Management: • Perform regulatory impact assessment by comparing the current registered information with the proposed changes to determine in collaboration with the Global Regulatory/ Country Regulatory Lead/ CMC strategist if Regulatory Change is required., • Review the regulatory requirements or guidelines (including from Regulatory Requirements Manager (RRM) to evaluate possible requirements in collaboration with GCMC?, • Ass needed, determine best case and worst case BOH approval timelines, align with Global CMC on timelines as needed, and share high-level estimation of the BOH approval timelines with the CMO, VSOT and PGS project team (if available)., • If appropriate, support the deployment and maintenance of client Common Technical Dossier (P-CTD) for the sharing of registered information to the CMO in collaboration with the VSOT, • If P-CTD is not deployed, share the latest approved CTD section with the CMOs after collecting them in PDM?, • Share the preliminary market regulatory impact assessment with the CMO, VSOT and PGS project team (if available)., • For changes impacting multiple sites, the CQRL should ensure that impacted sites are being informed of the proposed changes and obtain their concurrence prior to the implementation through the Global Change Request and Site Impact Assessment record in QMS., • Coordinate collection of regulatory supporting documents for the change control and registration as needed., • Support the PAC process in the VSOT, • Raise the Product Change Form (PC) in PDM to clearly specify the change form and to with justification, product impacted, specific markets impacted where the change will not impact on all markets, other impacted sites, and upload the supporting documents in collaboration with the GRL by the agreed timeline., • For products in PDM, route the PCF for Global CMC Market Impact Assessment., • Obtain from the CMO or other stakeholders as required and upload additional information when requested by Global CMC to justify the change and support market requirements., • Communicate the Market Impact Assessment (MIA) feedback from Global CMC or PCO (for single market products not in PDM) to the CMO, VSOT and PGS project team, if available., • Track regulatory submission status and approvals & rejections within digital system., • Monitor for BOH Queries through notification s from GCMC or the PCO., • Support Global CMC or PCO in completion of BOH queries. Inform the site and obtain the required documentation from the site to support the BOH queries., • Inform the site and PGS project team (if available) when specific markets are authorized to be implemented, when BOH approval is received, any BOH commitments made, and the BOH implementation date (if required)., • Escalate critical quality/compliance issues or major delays following the standard SOP/IMEx/VSOT reporting meetings., • Support License Renewals, New products registrations, Product Launches, Site Transfer, License Withdrawals and Tender applications following the same approach as above., • Support generation and collection of ancillary documents if applicable. Qualifications/Skills: • Minimally 10 years of experience in GXP setting and/or Regulatory Affairs role, • Expertise in external suppliers/contractors, Change Management and Regulatory., • Experience w/ relevant QTS & eQMS modules, • QRM practitioner, • Demonstrated technical know-how, knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices., • Is diplomatic, clear & succinct in communication with internal and external stakeholders, • Committed to the Change Management Best Practices to enable improvement of the Change Management Process and System., • Embraces innovation and change to find solutions., • Strong project management skills. Demonstrated success leading global Projects., • Collaborative and embraces Client mindset: Courage, Equity, Excellence, Joy; strong interpersonal and influential skills., • Proficient in English and technical writing and strong verbal, written communication, and presentation skills., • Decision-making based on a science-based risk approach., • Demonstrated experience managing complex quality and compliance activities, problem solving attitude and open to innovation, takes initiatives and is proactive, persistent., • Demonstrated ability to act and work independently and to report items as required to line manager., • Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: Syner-G is seeking a Sr. Process Engineer with 7–11 years of experience to lead the design, optimization, and automation of manufacturing and laboratory processes. This role will serve as a primary Subject Matter Expert (SME) for key cell therapy unit operations and will guide process monitoring, improvement initiatives, technical investigations, and technical transfers within cGMP environments. The Senior Process Engineer will provide strategic and hands-on support across process development, operations, quality, and regulatory functions, driving process robustness, efficiency, scalability, and compliance across client programs. WORK LOCATION: Travel to client sites may be required up to 100 percent, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) • Act as the primary SME for assigned cell therapy unit operations such as cell selection, gene transduction, cell expansion, and cryopreservation within cGMP manufacturing., • Provide Person-in-Plant (PIP) support during critical operations, ensuring real-time technical guidance and issue resolution., • Lead complex deviations and investigations to determine root causes and establish corrective and preventative actions (CAPAs)., • Establish and maintain process control strategies for critical process parameters (CPPs) and critical quality attributes (CQAs)., • Conduct data trending, process performance assessments, and modeling to identify improvement opportunities., • Propose and execute technical projects to optimize yields, reduce cycle times, and enhance process robustness and scalability., • Lead the development, optimization, and scale-up of manufacturing and laboratory processes across upstream, downstream, or formulation operations., • Oversee process automation initiatives, including equipment integration and implementation of advanced control strategies., • Lead commissioning, qualification, and startup of process equipment and automated systems., • Partner with automation, engineering, and operations teams to implement digital tools, process monitoring systems, and data-driven frameworks., • Troubleshoot high-impact equipment, process, and automation issues, providing technical direction to junior staff., • Lead technical transfer of manufacturing processes between development and manufacturing groups or across internal and external sites., • Ensure process consistency, scalability, and alignment with quality system expectations during transfer., • Author, review, and approve technical protocols, reports, memos, SOPs, and change control documentation., • Provide technical data and narrative content for regulatory submissions including IND amendments and CTA filings., • Support the evaluation, integration, and validation of new technologies or systems to ensure scalability, reliability, and operational readiness., • Work closely with Quality Assurance, Manufacturing Operations, Development, and Regulatory Affairs to align on technical strategies and execution plans., • Manage vendor relationships, equipment upgrades, and external technical partnerships. Education • 7–11 years of process engineering experience within biotech, pharmaceutical, or advanced manufacturing environments., • Extensive hands-on experience with automated process equipment such as bioreactors, chromatography systems, filtration skids, or formulation systems., • Strong familiarity with process automation platforms such as DeltaV, Rockwell, Siemens, or SCADA and PLC systems., • Proven experience leading process development, scale-up, equipment integration, and optimization initiatives., • Strong understanding of process engineering fundamentals, mass and energy balances, process control principles, and equipment design., • Ability to interpret and develop P&IDs, engineering drawings, and automation logic., • Advanced data analysis skills, including statistical methods, modeling tools, and engineering software., • Strong communication, leadership, and project management abilities. Physical Demands: Regular use of a computer, keyboard, and mouse; reaching with hands and arms; talking and listening. Frequent walking and sitting; occasional standing, stooping, or kneeling. Must be able to lift and carry objects up to 25 pounds. Requires close vision and ability to adjust focus. Work Environment: Indoor office environment with moderate noise, bright lighting, and typical office conditions. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $125,000 to $188000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job Description ABOUT GENALYTE At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, an automated decentralized lab featuring our novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities. WHY WORK FOR US We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career. POSITION SUMMARY The Supervisor, Clinical and Systems V&V is responsible for overseeing Research Scientists and Phlebotomists in day to day activities in the Phlebotomy and Validation team. The Supervisor will take a supportive role in activities relating to method feasibility, verification, validation, and transfer including oversight of change controls, protocol/Work Instruction generation, sample preparation and data evaluations. This position will work closely with the various product development teams to coordinate V&V activities and ensure planning activities are completed prior to initiation of V&V studies. As manager within the Clinical Affairs team, they will execute clinical studies in accordance with IVD clinical guidelines, applicable regulatory requirements, company SOPs, and study protocols. They will participate in the management of budgets and timelines, as well as all the tasks of clinical study and ongoing process of improvement of clinical standard operation procedures, work instructions and tools. A Manager of Clinical Affairs works for all the IVD product lines, including Immunoassay, Hematology and Clinical Chemistry. The Supervisor will interact with Project Managers, Assay Development, Quality and Regulatory to address problems, identify solutions, resolve timelines issues, and communicate conflicting project goals. Works with Manufacturing to set up and optimize production, communicate product manufacturing strategies, new processes, and new competency requirements. Works within our team to optimize downstream testing and to streamline with clinical as appropriate. Provides updates to Management and to Project Teams, when participating in cross-functional teams. Ensures all issues related to the success of the product launch are communicated to the Manager Quality Assurance. ESSENTIAL FUNCTIONS & RESPONSIBILITIES These may include but are not limited to: • Oversee laboratory inventory management, • Actively participates on design teams, understands project goals and timelines, and provides leadership to ensure product launch success, • Actively communicates project status, challenges, concerns, and resource constraints to area management, • Writes design control documentation and executes/oversees associated test and risk management activities, • Maintains project documentation in accordance with internal Genalyte and external regulatory requirements as part of the design control process, • Provides guidance to V&V, R&D or other functions as needed, • Carries out duties in compliance with established business practices and policies, • Provides support and guidance for troubleshooting method issues, • Resolves complex technical problems through teamwork, communication, and application of technical expertise, • Supports improvement verifications, validations, and transfers, • Develops, reviews, or approves execution protocols and group generated data, • Oversee studies, reviews protocol execution, and approves summary reports, • Effectively communicates with support groups across the company, • Maintains high levels of communication with other laboratory teams to support the coordination of shared resources, • Performs evaluations and action-item assignments related to change controls, • Reviews and approves document changes for SOPs and other technical documents, • Ensures group members have and use appropriate engineering controls, safety procedures and PPE. Encourages a strong culture of team and individual safety awareness and accountability, • Coordinates cross-functionally across the site to support project planning and execution, • Ensures an appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed, • Performs analysis and determines appropriate actions in investigations, deviations, CAPAs, and continuous improvement to ensure compliance with all GMP requirements, • Anticipates and troubleshoots issues regarding processes, procedures, and documentation, • Utilizes scientifically sound, risk-based approaches to determine the impact and root cause of issues as they are identified, • Develops and implements corrective actions, • Leads and develops best practices, • Independently supports the assay V&V vision on the project teams Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES • Bachelor’s Degree in Engineering, Science, related field or equivalent, • 2+ years of relevant experience in a pharmaceutical or medical device environment. ISO13485, ISO 62304 and FDA QSR experience., • Experience in development and implementation of standards, procedures, and guidelines in support of validated operational processes., • Ability to clearly articulate design verification and validation process concepts to the business community through written and oral presentations. Knowledge/Skills • Strong analytical and problem-solving skills, • Good organizational skills, and the ability to manage multiple tasks, • Experience in product development and experimental design, • Ability to work within cross functional teams, • Strong communication skills, written and verbal, • Must exhibit professionalism, confidence, maturity, a desire to succeed, proactivity, and self-motivation, • Strong knowledge of relevant analytical tools, • Ability to participate in planning and managing projects, • Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management), • Knowledge of related quality systems regulations and processes, • Appropriate computer skills (e-mail, word processing, statistical, spreadsheet software), • Ability to successfully complete projects while maintaining empathy for the team, • Persuasive, encouraging, and motivating, • Excellent negotiation and conflict resolution skills, • Flexible during times of change, • Ability to work in a startup-like culture and conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities, • Ability to understand and flex to different communication styles of team members and contractors who come from a broad spectrum of disciplines, • Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments Powered by JazzHR jyunjKrCiA

Job Description Description The Director of Clin Ops provides oversight across the biopharma company’s multi‑therapeutic, multinational infectious disease development programs. This role is responsible for designing, implementing, and overseeing robust global quality systems that ensure compliance with FDA, ICH, GLP, GCP, and GMP requirements. Working closely with executive leadership, Regulatory Affairs, Quality partners, CMOs, and external consultants, this position ensures comprehensive quality oversight across development, manufacturing, testing, and product‑release activities. The Director leads internal teams and external vendors, supports regulatory submissions and inspections, and drives continuous improvement of quality systems to enable successful regulatory approvals and commercialization. Primary Duties and Responsibilities -Provide overarching QA leadership for multi‑therapeutic, multinational development programs. -Oversee quality systems in collaboration with the CEO, Quality groups, the company’s CMO, Clinical Operations, GMP staff, and external consultants. -Develop project and budget plans, define team structures, and establish Quality Assurance and Clinical Quality Plans while initiating quality systems across functions. -Build Quality Assurance programs aligned with regulatory expectations and the stage of product development. -Partner with Regulatory Affairs to support preparation of CMC sections for INDs, CTAs, and IMPDs. -Ensure compliance with applicable regulations and internal policies, including FDA, ICH, and company procedures. -Select, oversee, and audit contract vendors to ensure compliance throughout product development. Conduct internal and external audits in accordance with GLP, GCP, GMP, and quality system requirements. -Provide QA oversight of development, manufacturing, validation, testing, and product‑release activities. -Prepare documentation and train staff for pre‑approval and regulatory inspections. -Conduct assessments, gap analyses, and quality‑system improvements to support successful regulatory outcomes. -Train staff in regulatory and compliance procedures. -Oversee, review, and approve internal controlled documents, including sponsor SOPs and associated training. -Ensure CRO and study‑site activities comply with sponsor SOPs and documentation standards. -Approve clinical trial material (IP) labeling for U.S. and global studies; coordinate proposals, review, and ordering of packaged and labeled IP with external vendors. Job Type & Location This is a Contract position based out of San Diego, CA. Pay and Benefits The pay range for this position is $96.00 - $115.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Job DescriptionCompany Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to , and follow us on X or LinkedIn. Reporting to the Senior Vice President of Quality, the Sr. Director of Quality will lead provide quality oversight of clinical development and manufacturing programs. This individual will lead the Chemistry, Manufacturing, and Controls (CMC) QA team and provide end-to-end development to manufacturing support for clinical stage programs and will develop systems to commercialize late-stage assets. This position will design, develop, and implement clinical and commercial quality strategies to ensure appropriate compliance to applicable regulatory regulations. The successful candidate will work closely with Technical Operations, Regulatory Affairs, and third-party Contract Development and Manufacturing Organizations (CDMOs) and will be responsible for all levels of studies, ranging from simple to complex and requires an in-depth understanding of GMPs, global Health Authority requirements, program management, quality systems, validation, and data integrity. Strong cross-functional team leadership and project management skills are essential requirements of the role. Job Description • Ensure compliance with all applicable local and global drug regulations., • Oversee Quality CMC functions with oversight and authority over batch disposition, manufacturing, packaging, labeling and testing activities to ensure product quality and timely release of materials and products., • Provide hands-on leadership to effectively facilitate quality functions related to batch disposition, investigations, process and analytical data review, supply distribution and risk management., • Serve as a point of contact for complex or high-risk quality issues and decisions., • Identify and manage quality risks across the product life cycle, recommend and support mitigation strategies., • Operate closely with ORIC technical operations team, Contract Manufacturing Organizations (CMOs), contract testing laboratories, and distribution sites to facilitate quality review of process/analytical data and reports, ensuring technical rigor and phase appropriate compliance to support program decisions., • Work cross-functionally with Regulatory Affairs to ensure timely and accurate review of submissions., • Operates closely with clinical program teams and serves as an active participant in clinical development meetings ensuring continuous quality support., • Develop performance-based quality metrics and trend analyses to drive continuous improvement., • Perform and present Annual Product Reviews for late-stage programs., • Lead, mentor and develop a high-performing Quality team effectively scaling the team to support clinical into commercial programs., • Serve as Chair or primary Quality member in various governance committees including ORIC’s Stability Review Board, Material Review Board and Change Review Board, • Represent ORIC Quality in CDMO meetings, regulatory authority interactions, strategic leadership meetings as needed., • Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies, workflows, and priorities in response to changing business needs, technologies, and stakeholder expectations., • Develop new functional, late phase, commercial ready SOPs, Policies/Plans as necessary.Qualifications, • Bachelor’s or Master’s degree in Chemistry, Biology, or a related scientific discipline, • 15+ years of relevant experience in Quality Assurance and/or Quality Control in the pharmaceutical industry., • 7+ years of prior senior leadership experience., • Deep hands-on knowledge in ICH, GMP, and regulatory guidance relevant to new drug development and commercialization. Experience with preparing for commercial stage operations and regulatory interactions preferred., • Experience over a broad set of Quality Assurance functions with extensive knowledge of industry best practices and trends., • Ability to understand business objectives and how they translate into quality priorities., • Demonstrated ability to develop a vision for Quality functions as it transitions through the phases of drug development to commercialization., • Demonstrated success in working with and managing CDMOs and external partners using succinct and thorough communication skills., • Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work., • Demonstrated initiative, ownership, problem identification, problem solving, and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met., • Results driven, collaborative leader with proven ability to perform in a fast-paced environment with a high attention to detail and demonstrated ability to manage and prioritize multiple competing tasks, • Excellent verbal and written communication skills, with the ability to build productive long-term team relationships at all levels of supplier organizations, including with senior executives, • Skilled at managing autonomous, high-performing professionals who value flexibility, while ensuring alignment, collaboration, and delivery of results. Additional Information The anticipated salary range for candidates who will work on-site at our San Diego location is between $220,000-$270,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Clinical Data Scientist will play a critical role in analyzing and interpreting clinical trial data, developing scientific materials, and supporting clinical development strategy across Arrowhead's pipeline. This individual will be part of the Clinical Development team and work with Biostatistics, Medical Writing, and other cross-functional R&D teams to translate complex datasets into meaningful scientific insights that inform internal decision-making, regulatory strategy, and external communication. This position requires a PhD-trained scientist with statistical knowledge, analytical capabilities, scientific storytelling skills, and the ability to operate in a fast-paced biotech environment. This is a fulltime, onsite position based from Arrowhead's Corporate Headquarters in Pasadena, CA or San Diego, CA. Responsibilities Clinical Data Analysis & Scientific Interpretation • Perform in-depth clinical data analyses to support ongoing studies and development programs., • Interpret clinical datasets and translate findings into clear, actionable insights., • Develop internal presentations and communicate results to key stakeholders, including senior leadership., • Identify trends, signal detection insights, and emerging data patterns to support program strategy., • Draft early-stage scientific abstracts, • Prepare and refine slide decks summarizing clinical data for internal and external audiences., • Support development of scientific narratives aligned with emerging data., • Assist Clinical Development with protocol input and clinical trial design considerations., • Contribute to endpoint selection, subpopulation strategy, and exploratory analyses., • Support preparation for key data readouts and milestone events., • Partner with Biostatistics to ensure appropriate analytical approaches., • Collaborate with Clinical Operations and Data Management to ensure data quality and readiness., • Support Medical Affairs and other functions in understanding emerging clinical insights., • PhD in a biological, biomedical, or medical discipline., • 3+ years of experience in biotech, pharmaceutical, academic translational research, or clinical data analysis roles., • Strong experience analyzing and interpreting clinical data., • Background in medical writing, clinical data science, or translational research., • Experience supporting clinical trial design., • Experience in early-stage development programs., • Familiarity with statistical tools (e.g., SAS, R, Python) or data visualization platforms, • Experience preparing scientific presentations and slide decks for internal stakeholders., • Experience drafting or contributing to scientific abstracts or publications., • Excellent written and verbal communication skills., • Strong analytical thinking and ability to synthesize complex datasets. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Job Description: We are seeking an experienced, collaborative, and strategic physician leader with deep expertise in obesity and metabolic disease clinical development to help build and execute the clinical vision for the Company’s portfolio. This role will be responsible for defining and driving clinical strategies across early- and late-stage development programs, with a particular focus on obesity, cardiometabolic, and related metabolic indications. The Senior Director, Clinical Development (MD) will play a critical leadership role in advancing innovative therapies through the clinic, combining scientific rigor, regulatory insight, and operational excellence. The ideal candidate brings a strong track record of leading obesity and metabolic clinical trials, working cross-functionally, and delivering high-quality clinical outcomes in a fast-paced biotech environment. Essential Responsibilities: Clinical Strategy & Leadership • Lead the development and execution of clinical development strategies for obesity and metabolic disease programs across multiple stages of development., • Provide medical and scientific leadership for clinical trial design, execution, and interpretation, including endpoint selection, patient populations, safety monitoring, and benefit–risk assessments., • Serve as the primary medical expert for obesity/metabolic programs, advising internal teams, investigators, consultants, business development partners, and investors., • Champion clinical excellence and accountability across all assigned programs., • Define clinical priorities and oversee the development of protocols, amendments, and integrated development plans tailored to obesity and metabolic indications., • Ensure delivery of high-quality clinical study outputs on time and within budget., • Act as the primary medical point of contact for regulatory agencies for assigned programs., • Partner closely with Regulatory Affairs, Clinical Operations, Program Management, CMC, and other functions to ensure alignment and execution., • Lead preparation, review, and contribution to key regulatory documents, including IND submissions, investigator brochures, clinical study reports, and regulatory briefing packages., • Participate in and support FDA/EMA meetings and regulatory interactions related to obesity and metabolic disease development., • Establish and maintain strong working relationships across clinical operations, regulatory, biostatistics, translational science, safety, and commercial teams., • Build and maintain relationships with key external stakeholders, including key opinion leaders in obesity and metabolic disease, investigators, consultants, and patient advocacy organizations. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Medical Degree (MD)., • Minimum 8+ years’ experience in leading clinical studies within the biotech/pharmaceutical industry., • Experience leading studies for obesity or metabolic disease in the pharma industry, • Minimum 5 years of leadership experience with excellent line management skills., • Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills., • A proven track-record of leading clinical trials at all stages., • Expertise in the areas of drug development, clinical operations and strategic planning., • Expertise in scientific and clinical data review and interpretation, including in-depth analysis and presentation of data from strategic perspectives, • Expertise with SOPs, GCP, ICH guidelines, regulatory compliance requirements, and risk mitigation strategies., • Experience with FDA/EMA processes (IND filing, NDA filings)., • Board certification in Endocrinology, Diabetes, Metabolism or similar discipline, • Experience in operations management within a clinical research setting., • Strong leadership skills with the ability to work in a dynamic, fast-paced environment., • Strong understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Attention to detail while discriminating between critical and non-critical activities and to follow established processes., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday, occasionally overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information.

Job DescriptionCompany Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to , and follow us on X or LinkedIn. Reporting to the Senior Vice President of Quality, the Director of Clinical Quality Assurance will lead the Clinical QA function and provide strategic leadership and operational oversight across global early to late-stage clinical programs. The role is responsible for the development, implementation and oversight of quality policies, procedures, and risk-based systems appropriate for advancement of clinical programs. This individual will ensure compliance with global regulatory regulations, as applicable. The successful candidate will work closely with Clinical Development, Clinical Operations, Regulatory Affairs, and third-party Contract organizations to prepare the team for BLA/BIMO milestones. An in-depth understanding of global Health Authority requirements, clinical program management, quality systems, validation, and data integrity are essential requirements of the role. Job Description • Ensure compliance with all applicable local and global clinical regulations., • Develop and execute a clinical QA strategic vision aligned to corporate and program goals., • Serve as the senior Clinical QA representative on program and study teams., • Provide hands-on leadership to develop, implement phase appropriate clinical quality systems, processes, SOPs and governance structures., • Review and provide QA input on clinical study-specific documentation., • Collaborate closely with Clinical Development, Clinical Operations, Pharmacovigilance, and Contract service partners to advance clinical programs to late-stage regulatory milestones., • Provide compliance direction on investigations into significant quality issues related to GCP elements, product handling, administration, or safety. Facilitate identification of root cause, and development of effective corrective and preventive actions. Ensure reporting of potential or confirmed violations to regulatory authorities in collaboration with Clinical Operations, Regulatory and Quality leadership., • Identify and escalate compliance risks, recommending mitigation plans to Clinical Development and Quality leaders., • Coordinate with cross-functional stakeholders to mature clinical and GCP training programs., • Execute a risk-based vendor audit program covering internal, vendor and clinical site audits., • Assess audit findings for impact on subject safety, data integrity, and business operations, and ensure timely CAPA development and closure., • Lead GCP inspection readiness initiatives, including mock BIMO interviews, inspection preparedness plans, and cross functional training., • Manage BIMO sponsor inspections and provide oversight/support for CRO inspections., • Develop performance-based quality metrics and trend analyses to drive continuous improvement., • Lead, mentor and develop Clinical QA personnel effectively scaling the team to support late-stage clinical programs., • Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies, workflows, and priorities in response to changing business needs, technologies, and stakeholder expectations.Qualifications, • Bachelor’s or Master’s degree in Life Sciences, or a related discipline, • 12+ years of relevant experience in Clinical Quality Assurance in the pharmaceutical industry., • 5+ years of prior leadership experience., • Expert knowledge of global GCP regulations and guidance documents including but not limited to:, • 21 CFR Parts 11, 50, 54, 56, 312, • EU Clinical Trial Regulatory (EU-CTR), • ICH E6(R2/R3), ICH E8, • General Data Protection Regulation (GDPR), • Good Clinical Laboratory Practice (GCLP), • Extensive experience with regulatory inspections, vendor qualifications, vendor audits, and internal audits., • Experience over a broad set of Clinical Quality Assurance functions with extensive knowledge of industry best practices and trends., • Ability to understand business objectives and how they translate into quality priorities., • Late-stage clinical and/or commercialization experience is a plus., • Demonstrated ability to develop a vision for Quality functions as it transitions through the phases of drug development to commercialization., • Demonstrated success in working with and managing contract/external partners using succinct and thorough communication skills., • Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work., • Demonstrated initiative, ownership, problem identification, problem solving, and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met., • Results driven, collaborative leader with proven ability to perform in a fast-paced environment with a high attention to detail and demonstrated ability to manage and prioritize multiple competing tasks, • Excellent verbal and written communication skills, with the ability to build productive long-term team relationships at all levels of supplier organizations, including with senior executives, • Skilled at managing autonomous, high-performing professionals who value flexibility, while ensuring alignment, collaboration, and delivery of results. Additional Information The anticipated salary range for candidates who will work on-site at our San Diego location is between $200,000-$220,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

Job Description Job Title: Director, Clinical Laboratories Department: Lab Srvc - Admin Are you passionate about making a real difference in your community? Are you looking for a job where you can contribute to a meaningful cause and grow professionally? If so, San Diego Blood Bank invites you to join our dynamic & diverse team dedicated to the mission of saving & improving lives through blood and biotherapies. WHY CHOOSE SDBB? At San Diego Blood Bank, we provide Southern California regional hospitals with a wide range of blood banking services. These include blood collection, component preparation, plateletpheresis, plasmapheresis, leukapheresis, washed blood, frozen blood, autologous storage, designated donation services, and a reference laboratory. San Diego Blood Bank’s Cord Blood Banking Program provides lifesaving stem cell transplants to patients worldwide. Founded in 1950, San Diego Blood Bank has been an important institution in the San Diego community for decades. Today, SDBB is continuing to grow to meet the changing needs of our healthcare community. San Diego Blood Bank is a 501(c)(3) nonprofit organization also operating as Southern California Blood Bank. We serve hospitals in San Diego, Los Angeles and Orange Counties. We are the primary blood provider to Rady Children’s Hospital-San Diego and the safety net for hospitals in our region. Every year, more than 150,000 units of blood provided by San Diego Blood Bank are transfused into patients of all ages, socio-economic and ethnic backgrounds throughout Southern California. These patients are struggling with life-threatening medical conditions including cancer and other blood disorders, severe burns, organ transplants, emergency surgery, trauma, childbirth complications and more. WHAT YOU NEED TO KNOW (Job Summary) The Director, Clinical Laboratories reports to the Chief Medical Officer /CLIA Laboratory Director and is responsible for facilitating the design and implementation of the delivery of laboratory services, developing and recommending strategies to improve services and clinical outcomes, reaching established goals, maintaining satisfactory outcomes and contributing to the business plans and financial goals of the organization. WHAT YOU WILL BE DOING TO MAKE A DIFFERENCE (Key Responsibilities): • Provide administrative and technical oversight of San Diego Blood Bank's clinical laboratories, including the Quality Control Laboratory, the lmmunohematology Reference Laboratory, and the Molecular Laboratory., • Create, perform review, and approve standard operating procedures, processes, test methods, equipment validations, and other regulated documents., • Ensure enrollment and participation in proficiency testing programs, review all results, investigate any unsatisfactory results, and implement corrective actions., • Acquire a high degree of familiarity with technical laboratory tasks (bench work) and be able to provide supervision, assistance, and personally perform hands-on bench work when limited staffing situations arise or workflow deems necessary., • Ensure annual competency assessment and ongoing training of all laboratory staff., • Assist department in preparing for external inspections., • Coordinate quality assurance and compliance-related activities with management and front-line staff., • Assist with new/renewal applications/submissions for AABB and CAP accreditation, California State biologics and laboratory licensure, CLIA certification (accreditation and waiver), FDA registration, as well as FDA license amendments., • Perform final review of deviations as needed., • Participate in innovative diagnostic test development., • Participate in corrective and preventive action teams, assist with investigation and root cause analysis, and verify that actions are implemented and effective., • Analyze data, identify trends, and report findings to management., • Conduct annual review of the laboratory quality plan, quality indicators, and process improvement initiatives in alignment with applicable laws, regulations and standards., • Participate in appropriate departmental meetings, and attend other meetings as assigned., • Enhance professional growth and development through participation in educational programs, current literature review, in-service meetings, and workshops., • Participate in regulatory/accrediting agency inspections., • Participate in clinical laboratory on-call responsibilities, • Participate on appropriate San Diego Blood Bank committees to facilitate communication of service needs, appropriate utilization management, and performance improvement efforts., • Participate in laboratory emergency preparedness and disaster recovery planning., • Aid in the development of informational/marketing materials., • Present medical/scientific/educational information to San Diego Blood Bank clients and staff., • Lead and/or assist in scientific manuscript and abstract preparation., • Maintain confidentiality of sensitive information concerning patients, employees, clients, vendors, and San Diego Blood Bank., • Contribute to the execution and reporting of relevant contract research projects., • Take a leading role in identifying and assessing additional opportunities for growth, including the negotiation of potential strategic alliances and/or product development., • Remain current on trends in laboratory medicine through continuing education, stakeholder and industry relations, and conferences., • Maintain knowledge of clinical professional standards of care and scope of practice for laboratory medicine including laboratory professionals., • Ensure laboratory staff are apprised of and aligned with San Diego Blood Bank's mission, vision, and strategic goals., • Ensure appropriate laboratory management staff collaborate with operational staff regarding decisions on matters relating to technical performance, compliance, quality, and finances., • Serve as a mentor to laboratory staff., • Support continuing education for laboratory staff and/or local/regional medical community, as needed or requested., • Fulfill the responsibilities of general supervisor, technical supervisor, clinical consultant, technical consultant, and/or technical supervisor, as delegated by the CLIA Laboratory Director, and as defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA)., • Provide leadership and ensure compliance with all applicable state and federal laws and regulations and with the standards of accrediting/certifying agencies., • Embody and promote an overall culture of compliance that encourages ethical conduct and a commitment to compliance with laws, regulations and standards., • Perform other related duties as assigned or requested. Working Environment • Normal laboratory environment with biohazard precautions., • May be exposed to the risk of blood borne diseases., • May be exposed to chemicals that may be hazardous., • May be called on to work or attend meetings at other than routinely scheduled hours., • Works primarily in office/business environment. Physical Requirements • Must be able to perform physical laboratory procedures when necessary., • Must be able to work on a computer 4 - 8 hours a day., • Must be able to move around office and attend meetings outside of office., • Ability to travel to other SDBB sites as needed. Equipment Used • Standard office equipment including personal computer, faxes and printers., • General laboratory equipment including but not limited to: cell washers, centrifuges, heat sealers, sterile docking devices, refrigerators/freezers, tubing strippers, weights, scales, balances, expressors if applicable in the laboratory department., • BECS (Blood Establishment Computer Systems). WHAT YOU NEED TO SUCCEED (Minimum Qualifications) Education: • California Clinical Laboratory Scientist (CLS), M.D., Ph.D., or M.D./Ph.D. (doctoral-degree scientist). Advanced degree (master's or doctoral) in relevant scientific discipline preferred for CLS-licensed candidates. Certifications/Licenses: • Current Clinical Laboratory Scientist (CLS) license issued by the California Department of Public Health, Laboratory Field Services (required for non-physician candidates)., • Board certification in Anatomic Pathololgy, Clinical Pathology or combined Anatomic/Clinical Pathology (required for M.D. and M.D./Ph.D. candidates), • Current State of California Physician and Surgeon license (required for M.D. and M.D./Ph.D. candidates) Experience: • Eight (8) years of progressively responsible and demonstrated experience in high level management at a reference or health system laboratory preferred., • Experience should include participation in U.S. Food and Drug Administration (FDA), State, Federal, and accrediting agency inspections, knowledge of regulatory accreditation and licensing requirements, and application of quality assurance principles., • Additional experience in transfusion medicine, blood bank services, cellular therapy services, umbilical cord blood banking, molecular testing, therapeutic apheresis service and/or translational or clinical research preferred. Background in laboratory developed molecular diagnostics, and/or next generation sequencing are particularly sought., • Experience serving as laboratory director, general supervisor, technical supervisor, clinical consultant, and/or technical consultant preferred. Skills: • Knowledge of operational characteristics, services and activities of a quality program and in principles and practices used in healthcare/laboratory management, governmental compliance, internal audits, risk management, or regulatory affairs., • Demonstrated abilities required to develop policies and procedures and manage budgets., • Strong understanding of laboratory operations., • Ability to approach challenges with confidence., • Ability to perform tasks per Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations, including following detailed standard operating procedures, maintaining training, deviation reporting and good documentation practices., • Strong attention to detail, precision and commitment to accuracy., • Ability to organize activities effectively, use effective problem-solving techniques, and make sound decisions., • Ability to communicate effectively and collaborate with internal and external customers., • Good organizational and time management skills; must be able to establish priorities and multi-task., • Excellent interpersonal and communication skills with a desire to forge strong professional relationships with laboratory staff and executive leadership team., • Demonstrated record of academic achievement through independent or collaborative research and scholarly publications., • Demonstrated commitment to diversity, equity, inclusion, and staff success., • Proficient in Microsoft Suite applications (Excel, Word, PowerPoint)., • California Clinical Laboratory Scientist License (CLS) or California Clinical lmmunohematologist Scientist License (CIS)., • Specialist in Blood Banking (SBB) or equivalent, preferred. BENEFITS FOR YOU We take care of you, while you take care of others. As a mission-based organization, we believe our team needs great support to do great work. Our comprehensive benefits help you in balancing home and work. With our resources and perks, you have amazing possibilities at the San Diego Blood Bank including: • Employees working 30 or more hours per week are eligible for employer sponsored health benefits (Medical, Dental, & Vision plans), • Earn up to 120 hours of paid vacation in your first year., • 7 paid Holidays + 1 personal holiday provided annually., • 40 hours of paid sick time provided annually., • 403(b) retirement plan with 3% employer match starting on your first day., • Employee Assistance Program - Free for employees and their families, • Service Awards and recognition.

Job DescriptionAbout Truvian Truvian is a fast-paced and disruptive healthcare company at the intersection of diagnostics and consumer technology. We are developing a fully automated benchtop system that delivers lab-accurate results from a small blood sample under 30 minutes—designed for use in retail clinics or private practice settings. Our proprietary platform, currently under FDA review, is built to make routine blood testing more accessible, affordable, and actionable. At Truvian, we’re not just building a product—we’re building a movement to empower people with better health data, on demand. We are a team of trailblazers committed to discovery, collaboration, and innovation. If you’re looking for meaningful work in a mission-driven environment, join us on our journey to transform healthcare. Position Summary Truvian is seeking a Staff Biostatistician to provide strategic and technical leadership in biostatistics for analytical and clinical study design, execution, and analysis. This is a hands-on role where you will lead statistical strategy while also performing analyses that contribute directly to regulatory filings, publications, and internal data reviews. You will work cross-functionally with teams in product development, regulatory affairs, scientific affairs, and marketing, playing a pivotal role in validating Truvian’s blood testing technology for market readiness. Here’s Why You’ll Love This Job • Lead statistical strategy for a breakthrough technology in diagnostic healthcare., • Contribute to a high-impact product launch and shape the future of patient-centered diagnostics., • Collaborate with passionate, mission-driven professionals in a fast-paced, agile work environment., • Enjoy perks including:, • Medical, dental, and vision coverage, • 401(k) plan, • Paid parental leave and flexible PTO, • Craft coffee, cold brew, and kombucha on tap, • Healthy snacks and a farm-to-table restaurant with an employee discount, • Provide statistical leadership for analytical and clinical studies across the product lifecycle., • Design protocols and statistical analysis plans; conduct analyses supporting regulatory submissions, validations, and publications., • Lead clinical trial statistical components, including sample size calculations and endpoint analyses (e.g., sensitivity, specificity, PPV, NPV)., • Perform data quality control and ensure consistency, accuracy, and regulatory compliance., • Prepare study reports, regulatory documentation, and scientific presentations., • Integrate data from multiple sources to drive evidence-based decision-making., • Support analytical verification and clinical validation efforts per CLSI guidelines., • Ph.D. in Biostatistics, Statistics, or a related field with 5+ years of industry experience, OR M.S. with 8+ years, OR B.S. with 12+ years in biostatistics within the IVD or Biotech space., • Proven experience designing and analyzing clinical and analytical studies for IVDs., • Strong working knowledge of regulatory frameworks and design control processes., • Proficiency with statistical software (e.g., R, Python, SAS, JMP, SPSS, Alteryx, Analyse-It)., • Deep understanding of clinical accuracy metrics and statistical methods for diagnostics., • Strong written and verbal communication skills to clearly explain statistical insights., • Ability to work independently in a startup environment and manage competing priorities. Physical Demands • Ability to lift and move up to 5 lbs. regularly, • Sitting and standing for long periods of time, • $164,000 – $200,000The salary range reflects a wide set of factors, including experience, education, skills, certifications, and organizational needs. Final compensation will be determined based on qualifications and internal equity. Equal Opportunity Employer Truvian is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. We welcome all qualified applicants regardless of race, color, religion, sex, gender identity, national origin, disability, age, or veteran status. Cover letters are strongly encouraged. Powered by JazzHR f9QMNZnA74

Job Description Job Description: The Principal Scientist, Toxicology will provide scientific and operational leadership for non-clinical toxicology activities supporting drug discovery and development programs. This role is responsible for the strategic design, execution, oversight, interpretation, and reporting of outsourced GLP and non-GLP toxicology and related nonclinical studies to support global regulatory submissions. Essential Responsibilities: Study Monitoring & Nonclinical Oversight • Serve as Study Monitor with responsibility for oversight of all phases of outsourced GLP and non-GLP studies, including study enabling activities, study setup, protocol development, on-site monitoring of study conduct at CRO sites, and review of data and reports., • Provide scientific guidance, feedback, and directives to Study Directors and non-clinical sub-team members, including coordination of:, • CMC/Formulation planning to support study requirements, including manufacture, release testing, and shipping, • Sample shipping and logistics in collaboration with Operations, • Study timeline development in partnership with Project Management, • Maintain GLP compliance for all aspects of GLP studies and ensure adherence to internal SOPs and regulatory expectations., • Archive final study reports and associated data in IQVIA in accordance with regulatory and company requirements., • Collaborate closely with multidisciplinary drug discovery and development teams including CMC, Clinical, Regulatory Affairs, Pharmacokinetics, Bioanalytical, and Project Management., • Interface with drug safety team leads and represent toxicology as the primary point of accountability for the design, execution, data interpretation, and reporting of in vivo toxicokinetic (TK), tolerability, and investigative studies., • Develop protocols, procedures, data templates, and report templates for non-GLP studies and ensure submission-ready study reports to support advancement of drug candidates., • Contribute to and/or author nonclinical sections of global regulatory filings, including Pharmacology, PK, and Toxicology sections for INDs, NDAs, Marketing Applications, and regulatory briefing documents., • Oversee and manage CRO performance, timelines, budgets, and deliverables to ensure high-quality outcomes., • Contribute to budget estimates for nonclinical studies and ensure actual costs remain aligned with projected budgets on a quarterly and annual basis. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • PhD in Toxicology, Pharmacology, or a related life science discipline (DVM or equivalent may be considered), • 8+ years of relevant experience in pharmaceutical or biotechnology drug development, with demonstrated leadership in nonclinical toxicology, • Extensive experience overseeing outsourced GLP and non-GLP toxicology studies, • Direct experience supporting IND and later-stage regulatory submissions, • Strong knowledge of global nonclinical regulatory requirements (FDA, EMA, ICH), • Proven ability to lead cross-functional teams and manage external vendors, • Excellent scientific writing, communication, and presentation skills, • Must be able to work independently as well in cross-functional team settings with supervision as needed., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director, R&D Financial Planning & Analysis (FP&A) will support the Arrowhead R&D organization in preparation of budgets, forecasts, long range plans, and strategic investments for growth. This role will collaborate with key stakeholders across the company, including but not limited to Clinical Operations, Regulatory, Medical Affairs, as well as oversight of our clinical trial portfolio. This role presents an exciting opportunity to shape R&D finance strategies, influence decision-making, and support clinical portfolio execution in a dynamic and growing organization. Excellent communication, leadership, and technical skills will be essential for this role, as well as a passion to be a part of the company's growth. This role is based in Pasadena, California or San Diego, California, with an expectation to be in office 5 days a week. Responsibilities • Financial Planning & Forecasting, • Lead the annual operating plan, rolling forecasts, and long-range financial planning processes for the R&D organization., • Support strategic initiatives such as pipeline investment decisions, external collaborations, and business development evaluations., • Act as a trusted advisor to senior leaders, translating operational plans into financial implications., • Analyze actual results versus plan and forecast, clearly communicating key drivers and emerging trends., • Clinical Finance & R&D Support, • Support clinical trial budgeting, forecasting, and accrual analysis, including CRO spend, investigator grants, patient costs, and pass-through expenses., • Monitor clinical program spend versus plan, identifying risks, opportunities, and timing impacts., • Partner with Clinical Operations, Program Management, and Accounting to ensure accurate forecasting, spend visibility, and financial close alignment., • Support portfolio-level decision-making, including program prioritization, scenario analysis, and development trade-offs., • Review, evaluate, and support negotiation of CRO and clinical vendor agreements, including study budgets, change orders, and contract amendments, to ensure cost efficiency, appropriate risk sharing, and alignment with development plans., • Provide financial diligence on clinical vendor proposals, assessing pricing structures, payment terms, scope assumptions, and financial risks in partnership with Legal, Procurement, and Clinical Operations., • Performance Management, • Enhance financial transparency and decision support through dashboards and executive-ready materials., • Develop and track KPIs related to R&D efficiency, clinical execution, and overall financial performance., • Recommend actions to improve cost discipline, forecast accuracy, and resource utilization., • Process, Systems & Continuous Improvement, • Lead enhancements to FP&A processes, models, and planning tools., • Drive best practices in forecasting, scenario planning, and financial reporting., • Partner with Accounting and IT on ERP and FP&A system optimization., • Team Leadership, • Lead, mentor, and develop the R&D FP&A and Clinical Finance teams, fostering a high-performing, collaborative culture., • Bachelor's degree in Finance, Accounting, Economics, or related field, • 10+ years of progressive FP&A experience, including 5+ years in a leadership role., • Highly proficient in Microsoft Excel, with experience building models, • Ability to gather, analyze and interpret information for completeness and accuracy; excellent attention to detail; excellent organizational skills, • Strong communication skills, ability to effectively interact with others at all levels– within and outside of finance. Ability to tailor communication to the audience to achieve desired results, • Self-starter with the demonstrated ability to work in a fast-paced atmosphere with minimal supervision, • CPA/MBA, • Experience with FP&A Planning systems (Anaplan experience a plus), • Experience with building financial models All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionAbout the role: The Quality Assurance (QA) Specialist is responsible for supporting quality planning and ensuring compliance across production and operational processes within a regulated environment. This role works closely with manufacturing, engineering, and cross-functional teams to establish and maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. The QA Specialist oversees quality processes throughout the product lifecycle, including reviewing and approving validation and quality documentation, managing deviations, CAPAs, and change controls, and ensuring that production activities meet defined quality standards. The role also supports internal and external audits, participates in vendor qualification activities, and helps maintain compliance with regulatory and industry requirements. In addition, the position contributes to continuous improvement initiatives by monitoring quality metrics, supporting LEAN initiatives, and providing guidance and training on quality processes and compliance. The ideal candidate is detail-oriented, collaborative, and experienced in quality assurance within regulated manufacturing or life sciences environments, with a strong ability to ensure quality is built into planning, production, and operational workflows. Key Responsibilities: • Ensure compliance with applicable standards and regulations (ISO 9001, GAMP 5, EU GMP Annex 11, 21 CFR Part 11)., • Review and approve validation documentation (e.g., URS, FRS, test protocols, test scripts)., • Conduct and support internal and external audits, including regulatory inspections., • Develop, implement, and maintain QA policies, procedures, and SOPs., • Perform risk assessments and support risk-based decision-making., • Monitor and report on quality metrics and KPIs., • Provide training and guidance on quality and compliance topics to cross-functional teams., • Manage deviations, CAPAs, change controls, and other quality records., • Participate in vendor qualification and software supplier audits., • Stay current with regulatory developments and industry best practices., • Minimum 5 years of experience in QA within a regulated software development environment., • Experience working with LEAN, • Strong knowledge of ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11., • Experience with validation of computerized systems and software quality assurance., • Excellent understanding of SDLC and software testing methodologies., • Strong analytical, problem-solving, and communication skills., • Ability to work independently and collaboratively in a fast-paced environment., • Bachelor’s or master’s degree in Life Sciences, Computer Science, Engineering, or related field., • Experience with electronic quality management systems (eQMS)., • Familiarity with Agile and DevOps environments., • Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) is a plus. Biosero provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. In addition, Biosero complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Biosero is committed to diversity and inclusion. We seek individuals from all backgrounds and appreciate and celebrate the diversity of our growing team. Powered by JazzHR 30K9e5ebwk

Job Description (Associate) Director, Clinical Scientist (Remote) Key Responsibilities • Provide scientific and strategic leadership in the planning and execution of clinical trials, including protocol development, study design, and data analysis., • Author and review clinical protocols, ICFs, CSRs and regulatory documents, • Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, to ensure the successful conduct of clinical studies., • Interpret clinical data, prepare study reports, and contribute to regulatory submissions and presentations for internal and external stakeholders., • Support investigator meetings, advisory boards and data monitoring committee meetings, • Stay current with emerging scientific literature, competitive landscape, and regulatory requirements relevant to Immuneering’s oncology therapeutic area., • Support the development of clinical development plans and contribute to the strategic direction of ongoing and future programs., • Work closely with CRO’s and have a can do, proactive biotech mindset. Qualifications & Education · PhD, PharmD, RN, or MD in a relevant scientific discipline (e.g., biology, pharmacology, medicine). · Minimum of 5-8 years of experience in clinical development within the pharmaceutical or biotechnology industry. · Direct Phase 3 oncology clinical trial experience required. · Demonstrate experience authoring and reviewing clinical documents. · Demonstrated strong experience in clinical trial execution and data interpretation. · Strong analytical, organizational, and communication skills. · Deep understanding of oncology clinical development, endpoints and regulatory expectations. Technical / Soft Skills · Excellent cross-functional communication and stakeholder management. · Ability to work collaboratively in a fast-paced, team-oriented environment. · Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable) Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety. As an External Quality Operations Manager (EQOM), you’ll play a pivotal role in overseeing the quality performance of external manufacturing partners. Acting as the primary point of contact for these suppliers, you’ll ensure that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds Sobi’s global quality standards. You’ll be the bridge between Sobi and its external network, driving compliance, collaboration, and continuous improvement to support reliable product supply and Sobi’s fast‑growing global footprint. This role offers the opportunity to work cross‑functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening Sobi’s commitment to delivering high‑quality medicines to patients worldwide. Key responsibilities: * Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO) * Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement. * Support release products to Markets * Support the External Service Provider (CMO) Qualification * Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier * Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product Quality performance * Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA. Assess the performance of the product and the process as per Sobi requirement * Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement * Ensure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements * Support that Quality Audits of the CMO are performed according to Sobi requirement and the QTA * Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization * Lead or act as Quality representative in projects related to CMO eg Tech Transfer, Launch * Assess and ensure CMO for Health Authorities (HAs) inspection readiness * Support HA inspections/audits of Sobi * Responsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy * Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally * Ensure the batch release as required Qualifications Required: * High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science * More than 5 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP) * More than 1 years of managing external quality oversight of CMOs * Curriculum is requested for evaluating the batch release qualification requirement * Fluently spoken and written English Desired: * More than 2 years of working in global operation environment with English as a main language * Proven experience of leading Quality KPI assessment and improvement at CMOs * Proven track record with FDA; EMEA or other Health Authorities * Strong understanding of risk assessment and risk management fundamentals / tools What You’ll Bring To thrive in this role, you’ll combine deep knowledge of GMP and GDP regulations with proven experience in quality oversight of Contract Manufacturing Organizations (CMOs). You’re confident operating in a global, fast‑moving environment, using your leadership and interpersonal skills to influence external partners and drive collaborative decisions. You naturally build strong relationships — both within Sobi and with CMOs — and you know how to balance compliance with practical solutions that keep supply moving. Highly organized and skilled in planning and prioritization, you coordinate multiple deliverables with precision. As a leader, you take pride in coaching and developing others, fostering a culture of accountability and high performance across the quality network. Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. The base salary range for this role is $130,000-$153,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to Know Your Rights

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 diseases 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: Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled and experienced Program Director to lead cross-functional programs within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio. This role will oversee complex product development initiatives from concept through commercialization, ensuring alignment with strategic objectives, regulatory compliance, and time/cost constraints. The ideal candidate will have a strong background in project/program management, deep understanding of the biotech/IVD landscape, and a proven track record in delivering results through collaboration and leadership. Key Responsibilities: • Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch., • Develop and manage detailed program plans, timelines, budgets, and resource allocation., • Serve as the primary point of contact for program status, risk assessment, and issue resolution., • Drive strategic alignment across stakeholders and ensure program goals are met in accordance with company objectives., • Track key milestones and prepare executive-level reporting on program performance and progress., • Facilitate effective communication across internal teams, senior leadership, and external partners., • Ensure programs meet regulatory requirements (e.g., FDA, ISO 13485) and support submission readiness., • Manage program governance, including steering committee meetings and stage gate reviews. Qualifications: • Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree (MS, PhD, or MBA) preferred., • 8-10+ years of experience in the biotech, diagnostics, or medical device industry, with a focus on IVD product development., • 5+ years of program/project management experience in a regulated environment., • Strong knowledge of regulatory pathways, quality systems (e.g., ISO 13485), and clinical development for IVDs., • Proven ability to lead cross-functional teams and manage complex programs with multiple stakeholders., • Life Science/ IVD industry experience preferred., • PMP certification or formal training in project/program management strongly preferred., • Excellent communication, leadership, and organizational skills., • Experience with global product launches and managing distributed teams., • Familiarity with Agile and/or Stage-Gate development methodologies., • Prior experience working with external partners and managing outsourced development/manufacturing., • 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 DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: The Senior Director of Regulatory Affairs is responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements. The ideal candidate will have a strong background in cell and gene-modified cell therapy, expertise in global regulatory requirements, and preferably late-stage development experience. Duties/Responsibilities: • Support the preparation, review, and submission of regulatory filings, including INDs, CTAs, BLAs, and MAAs, ensuring compliance with global regulatory requirements., • Assist in compiling and organizing regulatory documents and responding to health authority queries., • Work closely with cross-functional teams, including Clinical, Pharmacovigilance, Biometrics, and CMC, to ensure accurate and complete regulatory submissions., • Maintain up-to-date knowledge of global regulatory requirements and contribute to regulatory intelligence efforts., • Support regulatory interactions with global health authorities by preparing meeting materials and responses to requests., • Contribute to the development of regulatory documentation, including CTD dossiers, IBs, clinical protocols, nonclinical and clinical study reports., • Assist in tracking regulatory commitments and timelines to ensure timely submissions and approvals., • Provide hands-on support in assessing emergent clinical data and operational activities for regulatory compliance. Professional Experience/Qualifications: • Bachelors degree required; advanced degree preferred., • 10+ years experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, formal meetings) with at least 5 in the cell and gene therapy space., • Strong knowledge of regulations and guidelines across multiple global jurisdictions, including the U.S., EU, and other key regulatory agencies., • Hands-on experience in the preparation and submission of regulatory filings (e.g., INDs, CTAs, BLAs, and MAAs)., • Strong organizational skills and attention to detail, with the ability to manage multiple priorities effectively., • Excellent written and verbal communication and collaboration skills to work effectively with cross-functional teams., • Ability to thrive in a fast-paced environment and adapt to changing regulatory requirements. Why you should apply: We have a fantastic team and philosophy! We are passionate We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit.We are transparent - believers in flat, accessible, and open communication paths.We are inclusive committed to the diversity of our team and ensuring that all voices are heard. 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: $240,000 - $260,000. Exact compensation may vary based on skills and experience.

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 CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. Essential Duties and Responsibilities: • Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development., • Represent GPV in communication with health and regulatory authorities., • Represent GPV at independent Data Safety Monitoring Committee meetings., • Provide medical oversight of the GPV function including medical review of all cases., • Provide medical input for maintaining REMS, RMP safety monitoring commitments., • In collaboration with other members of GPV, create and maintain a signal detection process for Erasca's products with a clearly defined signal detection strategy for each asset., • In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments., • Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems., • Provide periodic benefit-risk assessment reports for internal use., • Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities., • Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc)., • Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates., • Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis., • Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources., • Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met., • Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors., • Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs., • Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered., • 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred., • Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications., • In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation., • Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred., • Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred., • In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases., • Direct management experience with proven ability to effectively lead, coach, mentor, and manage others., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment., • Effective interpersonal, communication and influencing skills, including excellent writing 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. 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 About the Role We are seeking an experienced Project Manager to serve as the company representative on complex, high-profile federal construction projects ranging from $5M to $17M+. This leader will oversee all administrative, financial, contractual, and operational aspects of assigned projects—from pursuit through close-out—ensuring they are delivered safely, profitably, on schedule, and to the highest quality standards. This role is ideal for a strategic, hands-on construction leader experienced in Federal Contracting, or operationally sensitive environments (e.g., City Parks, public infrastructure, occupied facilities), Public Works (state, county, schools, cities), that is Park, sports facilities, and roads. Federal Projects (US federal government agencies) like the US Army, Veterans Affairs, GSA, Department of defense and the typical projects are: Military Bases, Federal office buildings, Border facilities, and VA hospitals, who thrives in a high-performance, team-oriented culture. Key Responsibilities Project Leadership & Oversight • Manage multiple project phases, including preconstruction, procurement, scheduling, execution, contract writing, buyouts, and close-out., • Develop and implement project plans outlining scope, timelines, risk mitigation, and resource allocation., • Prepare and maintain Projected Final Cost Reports (PFR) and Labor Cost Reports (LCR)., • Oversee owner billings and subcontractor pay applications, • Lead change order processes, ensuring accurate documentation and cost control., • Track quantities and forecasts to maintain accurate budgets and beat estimated costs., • Support estimating, proposal development, and client presentations., • Participate in interviews and pursue strategy as a project champion., • Collaborate with preconstruction and design teams to align scope, cost, and schedule., • Develop subcontract scopes, manage bid solicitations, conduct scope reviews, and finalize agreements., • Contribute to Minority Business Enterprise (MBE) plans and sustainability initiatives as required., • Partner with scheduling teams, superintendents, subcontractors, and suppliers to create and maintain achievable construction schedules and communication with the admin team for compliance., • Ensure procurement aligns with production timelines and long-lead material requirements., • Stay ahead of crew needs to maximize field efficiency., • Promote a culture of safety and zero incidents across all phases of work., • Implement safety, loss prevention, EEO, risk management, and quality control programs., • Participate in safety training, field inspections, and project review processes., • Supervise and develop Project Engineers and support staff., • Provide mentorship, accountability, and actionable feedback., • Foster collaboration across field and office teams., • Demonstrate initiative, integrity, and ownership in all responsibilities., • B.S. in Construction Management, Engineering, or related field (or equivalent experience)., • 8–10+ years of experience in heavy civil, commercial, or complex general contracting projects., • Experience managing $5M–$17M+ public entity projects; public entity experience required., • Proven success in managing multiple projects simultaneously., • Experience in operationally sensitive environments (e.g., Army, NAVFAC) is highly desirable., • Strong financial acumen and contract administration expertise., • Proficiency in RMS, Primavera6, Bluebeam, Sage /Timberline, and Microsoft Office., • Excellent written and verbal communication skills. This is an active, hands-on leadership role requiring significant time on construction sites, including: • Exposure to varying weather conditions and moderate to high noise levels., • Navigating uneven terrain, elevated work areas, and confined spaces., • Occasional lifting up to 50 pounds., • Extended hours during critical project phases. Successful candidates demonstrate: • Strategic Thinking: Ability to see the big picture while managing tactical execution., • Decisiveness: Makes thoughtful, timely decisions that keep projects moving forward., • Accountability: Takes ownership of results and holds others accountable., • Collaboration: Builds strong, respectful working relationships across all stakeholders., • Drive: Thrives in a high-performance environment and remains composed under pressure. We offer a competitive total compensation package including: • Medical, Dental, & Life Insurance, • 401(k), • Profit Sharing Equal Opportunity Employer We are an Equal Opportunity Employer committed to building a diverse and inclusive workforce. All qualified applicants will receive consideration for employment without regard to any protected status under federal, state, or local law. If you are a driven construction leader ready to take ownership of complex, high-impact projects and build lasting client relationships, we encourage you to apply. Company DescriptionBilbro Construction Company, Inc. was founded in 1997, and through the years, it has earned a reputation as one of San Diego's most respected, mid-sized general contractors. Bilbro Construction Company pursues projects demanding a high level of expertise and close attention to detail. The firm has recognized expertise in the construction of healthcare and laboratory facilities, private schools, universities, commercial and industrial buildings, retail centers, and high-value interior improvements. MarCon Engineering Inc. acquired Bilbro Construction Company in 2010. Bilbro Construction Company Inc. has been awarded a Naval Engineering Command (NAVFAC) Southwest firm fixed-price, indefinite-delivery/indefinite-quantity (IDIQ) multiple award construction (MACC) contract for new construction and renovation of general building construction. Since 2009, Bilbro Construction Company, Inc. has made a successful transition into the federal construction industry.Bilbro Construction Company, Inc. was founded in 1997, and through the years, it has earned a reputation as one of San Diego's most respected, mid-sized general contractors. Bilbro Construction Company pursues projects demanding a high level of expertise and close attention to detail. The firm has recognized expertise in the construction of healthcare and laboratory facilities, private schools, universities, commercial and industrial buildings, retail centers, and high-value interior improvements. MarCon Engineering Inc. acquired Bilbro Construction Company in 2010.\r\n\r\nBilbro Construction Company Inc. has been awarded a Naval Engineering Command (NAVFAC) Southwest firm fixed-price, indefinite-delivery/indefinite-quantity (IDIQ) multiple award construction (MACC) contract for new construction and renovation of general building construction. Since 2009, Bilbro Construction Company, Inc. has made a successful transition into the federal construction industry.

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: Senior Regulatory Affairs Manager Location: Onsite - Atlanta, or San Diego Position Summary: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices. Key Responsibilities: • Prepare, review, and submit regulatory documents to FDA., • Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals., • Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards., • Provide regulatory guidance to R&D team during product development life cycle., • Stay updated on changes in regulatory requirements and communicate potential impacts to the organization., • Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways., • Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines., • Represent the company in meetings with regulatory agencies and external partners as needed., • Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred., • Minimum of 7-10 years of experience in regulatory affairs within the medical device industry., • Proven track record of leading and successfully obtaining 510(k) and clearances/approvals., • Experience in interacting with FDA and other regulatory agencies. Skills & Competencies: • In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations., • Strong leadership and project management skills, with the ability to manage multiple projects and priorities., • Excellent communication, negotiation, and problem-solving skills., • Ability to work collaboratively in a cross-functional team environment., • 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 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 Description We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements. Job Type: Full time Job Title: Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities · Prepare and submit 510(k) applications for IVD products to ensure timely market entry. · Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory bodies, as needed. · Conduct regulatory risk assessments and develop mitigation strategies for IVD products. · Stay updated with regulatory changes and ensure all IVD products comply with current regulations. · Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions. · Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization. · Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance. · Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company’s products. Requirements · Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field. · Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions. · Strong understanding of FDA regulations, guidance documents, and processes related to IVD products. · Experience in interacting with regulatory agencies, particularly the FDA. · Excellent analytical, organizational, and communication skills. · Detail-oriented with the ability to manage multiple projects simultaneously. Preferred Skills RAC certification or similar. Benefits • Health Care Plan (Medical), • 401K, • Paid Time Off and Paid Sick Leave

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 & Compliance Specialist Location: Onsite - San Diego Salary Range: $90,000 - $95,000 Position Summary: The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. This role will work closely with cross-functional teams to support product development, manufacturing, and post-market activities. The specialist will ensure that all documentation and files related to diagnostic development are completed in a timely manner and are ready for inspections. Key Responsibilities: • Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, ISO 13485., • Provide regulatory guidance during the product development process, ensuring that products are designed and developed in compliance with applicable regulations., • Participate in risk management activities, including the development and maintenance of risk management files according to ISO 14971 and FDA 21 CFR Part 820., • Conduct risk assessments and work with product development teams to mitigate identified risks., • Participate in design reviews meetings and validation activities, ensuring that regulatory and quality requirements are met., • Review and approve design control documentation, including design input and output, design verification and validation protocols, ensuring that all documentation meets regulatory requirements., • Review and approve design history file for each new product., • Education:, • Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience., • Advanced degree or certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., CQE, CQA) is a plus., • Experience:, • 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry., • Experience with regulatory submissions, including 510(k) and CE marking, is highly preferred., • Strong knowledge of global regulatory standards, including FDA regulations and ISO 13485., • Skills:, • Strong understanding of IVD product development and manufacturing processes., • Excellent written and verbal communication skills, • Strong analytical and problem-solving skills, with attention to detail and accuracy., • Ability to work independently and as part of a team, with strong organizational and time-management skills., • High level of integrity and commitment to upholding regulatory and quality standards., • Proactive approach to identifying and addressing compliance risks and issues. Benefits • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

Job Description Director, Clinical Project Management (Remote) Position Summary The Director of Project Management will oversee and drive the execution of global clinical trials in oncology. This leadership role is responsible for ensuring the successful planning, implementation, and completion of complex clinical programs, collaborating with cross-functional teams and external partners worldwide. Key Responsibilities • Lead the strategic planning and operational execution of global oncology clinical trials, ensuring projects are delivered on time, within scope, and budget., • Work with cross-functional project teams, including Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Data Management, and external vendors., • Develop and maintain detailed project plans, timelines, and risk management strategies for all assigned studies., • Monitor trial progress, proactively identify issues, and implement solutions to ensure quality and regulatory compliance., • Contribute to process improvement initiatives and best practices in global project management., • Work closely with other professional project managers who work in our early stage development programs. Education & Qualifications • Bachelor’s degree in life sciences, healthcare, or related field; advanced degree (MS, PhD, MBA) preferred., • Minimum of 8 years’ experience managing global clinical trials in oncology, with demonstrated leadership in complex, multi-center studies and global regulatory submissions., • Proven track record in project management within the biopharmaceutical industry., • Strong understanding of regulatory requirements (FDA, EMA, ICH-GCP) for global clinical development., • Ability to travel domestically and internationally as required. Technical / Soft Skills • Exceptional communication, organizational, and leadership skills., • Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable) Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job DescriptionAbout Truvian Truvian is a fast-paced, disruptive healthcare company at the intersection of diagnostics and consumer technology. We’re building a fully automated, benchtop diagnostic system that delivers lab-accurate results from a small blood sample in just 30 minutes. Designed for retail clinics and private practices, our platform is currently undergoing FDA review and aims to revolutionize routine blood testing by making it more accessible, affordable, and actionable. At Truvian, our mission goes beyond the lab. We are committed to empowering individuals with timely health data and fostering a culture of innovation, collaboration, and discovery. Join us and help realize our vision of transforming routine health testing for today’s connected consumers. Position Summary Truvian is seeking an experienced and hands-on Regulatory Affairs Director to lead and execute all aspects of the company’s global regulatory strategy. This leadership role will be responsible for supporting regulatory submissions and product registrations across domestic and international markets, ensuring compliance with applicable regulations, and enabling timely product commercialization. The ideal candidate must have extensive experience in the in vitro diagnostics (IVD) industry, with a strong track record of leading both FDA 510(k) and CLIA Waiver submissions through to successful clearance. This individual will work cross-functionally with internal stakeholders, regulatory bodies, and international partners to ensure our technology meets all applicable requirements while aligning with Truvian’s mission to transform diagnostic testing. This position is onsite and reports to the Head of Quality & Regulatory. This is a high-impact, hands-on role based at our corporate headquarters in San Diego, California. Key Responsibilities • Support the regulatory strategy for Truvian’s portfolio of IVD products, ensuring proactive planning and timely execution of submissions to FDA (510(k), CLIA Waiver), Health Canada, European Notified Bodies (CE Mark/IVDR), and other international agencies., • Support the end-to-end regulatory submission process, including the development of submission dossiers, gap assessments, pre-submissions, and agency interactions., • Work with the regulatory team to ensure a comprehensive regulatory roadmap aligned with product development and commercialization milestones., • Provide regulatory guidance during all phases of product development, from concept through design transfer, clinical validation, and market launch., • Ensure all product documentation, including labeling, advertising, and promotional materials, meets regulatory requirements., • Interpret and communicate complex regulatory requirements to internal stakeholders in a clear and actionable manner., • Support regulatory impact assessments of product and process changes; oversee documentation updates and change control., • Monitor and implement evolving global regulatory requirements (e.g., IVDR transition, ISO 13485 updates) and translate them into internal strategies and processes., • Support post-market regulatory activities, including vigilance reporting, field actions, and annual reporting obligations., • Collaborate with OEMs, distributors, and international partners to align global regulatory strategies and support international market entry. Required Qualifications, • Bachelor’s degree in Life Sciences, Engineering, or a related discipline required; advanced degree (MS, PhD) strongly preferred., • 12+ years of experience in Regulatory Affairs, with a minimum of 8 years in the IVD industry., • Proven success leading and managing FDA 510(k) and CLIA Waiver submissions and approvals; experience with De Novo submissions is a plus., • In-depth knowledge of U.S. FDA regulations, CLIA requirements, EU IVDR, ISO 13485, and other global regulatory standards relevant to IVDs., • RAC certification preferred (U.S., Global, or EU)., • Demonstrated ability to translate complex regulatory guidance into practical regulatory strategies., • Experience interfacing with regulatory bodies, including preparation for and participation in agency meetings and audits., • Strong organizational, project management, technical, and analytical skills, with a high level of attention to detail., • Exceptional verbal and written communication skills, including the ability to influence and lead cross-functional teams., • Impactful Mission: Join a passionate team revolutionizing point-of-care blood diagnostics and making a tangible difference in healthcare access., • High-Energy Environment: Thrive in a fast-paced, high-growth startup that values innovation, collaboration, and purpose., • Comprehensive Benefits Package, including:, • Medical, Dental, Vision, and Life Insurance, • Flexible Paid Time Off (PTO) and Paid Parental Leave, • 401(k) plan with generous company match, • Wellness Perks:, • On-site gym and fitness classes, • Access to a farm-to-table café with a 30% employee discount, • No Travel Requirements, • May require up to 10% travel FLSA, • Exempt Work Location, • $168,000 - $186,000, • This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on final candidate qualifications and experience. Placement within the compensation range is determined by level, band, internal equity, and relevant qualificationsPhysical Demands, • Ability to lift and move up to 5 lbs., • Frequently standing and sitting for long periods. Equal Opportunity Employer Truvian is an Equal Opportunity Employer. We are committed to building a diverse and inclusive team where everyone belongs and thrives. All employment decisions are made based on qualifications, merit, and business needs — never based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status. Powered by JazzHR 2FpAD6Mi8I

The role will report directly to the Director of Regulatory Affairs and contribute to advancing development programs through key regulatory milestones. As part of this growth, the organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory team in San Francisco. Ensure regulato

Seeking an Associate Director, Regulatory Affairs leader to drive global regulatory submissions (IND/CTA) and shape the development of a cutting-edge small molecule portfolio. Senior Director, Regulatory Affairs. With nearly half a billion in total funding, this Rare disease biotech brings a unique

They are seeking a Senior Vice President of Regulatory Affairs to oversee all regulatory activities and be their primary strategic advisor on global regulatory strategy. Build, lead, and manage the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the compa

With strong early momentum and a clear path toward clinical and regulatory milestones, the team is looking to bring on a Vice President of Regulatory Affairs & Quality to build and lead the entire RA/QA function from the ground up. Regulatory Affairs / Quality within medical devices. Vice President,

Serve as the regulatory lead on cross-functional project teams, providing regulatory guidance to ensure alignment with clinical, CMC, nonclinical, and corporate goals. Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based i