Director/Head, Pharmacovigilance Orca BioDirector/Head, PharmacovigilanceMenlo Park, CALead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
Pharmacovigilance Expert - Remote YO AI LabsPharmacovigilance Expert - RemoteSan Francisco, CARemoteIn this role, you will help improve next-generation AI systems by reviewing, evaluating, and refining pharmacovigilance documentation, safety reports, and regulatory content. Experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus.
Associate Director, Pharmacovigilance Operations Nurix Therapeutics IncAssociate Director, Pharmacovigilance OperationsBrisbane, CA$229,500–$255,867 / yearThis role serves as the PVO lead for assigned products, driving in-stream quality review, regulatory submission oversight, retrospective quality review, and reconciliation activities, while partnering cross-functionally with Clinical Operations, Data Management, and Regulatory Affairs. Position: The Associate Director, Pharmacovigilance Operations (PVO) is responsible for all PV operational and compliance aspects of assigned Nurix products across the product lifecycle - from First-In-Human (FIH) studies through post-marketing - and for oversight of the end-to-end management of Individual Case Safety Reports (ICSRs).
Director/Head, Pharmacovigilance Orca Biosystems IncDirector/Head, PharmacovigilanceMenlo Park, CA$200,000–$245,000 / yearLead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
NewVP, Clinical Development Rigel Pharmaceuticals, Inc.VP, Clinical DevelopmentSouth San Francisco, CA$336,000–$405,000 / yearReporting to the Chief Medical Officer (CMO), the Vice President, Clinical Development provides executive leadership for the company’s clinical research and development activities within designated therapeutic areas and/or programs. The Vice President, Clinical Development serves as a senior leader within Clinical Development, accountable for clinical trial execution, data integrity, regulatory readiness, and cross-functional alignment.
Director, RA Gateway RecruitingDirector, RASan Francisco, CAManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
Sr. Pharmacovigilance Clinical Scientist Dawar ConsultingSr. Pharmacovigilance Clinical ScientistSouth San Francisco, CaliforniaThe position worksautonomously as a subject matter expert, supports vendor oversight, drivesquality and process improvements, and may lead projects and train internal andexternal teams. This role ensures case processing,follow-up, labeling assessments, and Health Authority submissions comply withcompany SOPs, PV regulations, and applicable global requirements.
Associate Director, Pharmacovigilance Operations Summit Therapeutics plcAssociate Director, Pharmacovigilance OperationsPalo Alto, CASupport and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA/SDEA compliance. Work cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, Commercial, and Medical Affairs to ensure appropriate PV processes are in place and adhered to.
NewSenior Director, Regulatory Affairs ImmunEdge, IncSenior Director, Regulatory AffairsRedwood City, CAFull timeWith a highly experienced team of experts in immunology and drug development, we are pioneering innovative approaches to target and modulate key molecular pathways that regulate the immune response. . This individual will serve as a strategic regulatory partner to Clinical Development, Clinical Operations, Research, Translational Medicine, CMC, Nonclinical, Quality, Pharmacovigilance, and executive leadership.
NewSr. Pharmacovigilance (PV) Clinical Scientist SGA Inc.Sr. Pharmacovigilance (PV) Clinical ScientistSouth San Francisco, CA$49–$63.40 / hourMaintains robust knowledge of Technical Product Complaints (TPC) & Medical Product Complaint (MPC) for all company products including combination products Responsible for ensuring all product complaints are reported to the appropriate stakeholders within defined timelines. Ensures appropriate due diligence to obtain missing and/or additional information for Adverse Events (AEs) is performed in accordance with company SOPs / local and global regulations Escalates any issues pertaining to follow up activities and provide strategic resolution to USPS management.
Sr. Pharmacovigilance (PV) Clinical Scientist Software Guidance & AssistanceSr. Pharmacovigilance (PV) Clinical ScientistSouth San Francisco, CA$49–$63.40 / hourMaintains robust knowledge of Technical Product Complaints (TPC) & Medical Product Complaint (MPC) for all company products including combination products Responsible for ensuring all product complaints are reported to the appropriate stakeholders within defined timelines. Ensures appropriate due diligence to obtain missing and/or additional information for Adverse Events (AEs) is performed in accordance with company SOPs / local and global regulations Escalates any issues pertaining to follow up activities and provide strategic resolution to USPS management.
Clinical Development Scientist/Senior Clinical Development Scientist Tenvie Therapeutics IncClinical Development Scientist/Senior Clinical Development ScientistBrisbane, CARemote$125,000–$180,000 / yearTenvie Therapeutics is seeking a scientifically rigorous and highly collaborative Clinical Scientist to support the design and execution of early clinical development programs across multiple indications including cardiometabolic and neuroinflammatory diseases. Lead or co‑lead the scientific design of Phase 1-2 studies (e.g., FIH, dose‑finding, PoC) including objectives, endpoints, inclusion/exclusion criteria, and biomarker strategy, Integrate nonclinical, translational, and clinical data to inform dose selection, schedule, and patient population.
Associate Director, Pharmacovigilance Operations Summit Therapeutics IncAssociate Director, Pharmacovigilance OperationsPalo Alto, CA$174,000–$205,000 / yearHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA/SDEA compliance.
Sr. Clinical Research Associate Structure Therapeutics IncSr. Clinical Research AssociateSouth San Francisco, CA$135,000–$145,000 / yearOverall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
Project Manager -Oncology Novotech Health Holdings Pte LtdProject Manager -OncologySouth San Francisco, CABy offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. Project Managers are expected to have a solid understanding of the drug development and clinical trial process, the role and workings of a Clinical Research Organisation (CRO), ICH GCP, international and local regulatory requirements.
Project Manager - Gen Med Novotech Health Holdings Pte LtdProject Manager - Gen MedSouth San Francisco, CABy offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. Project Managers are expected to have a solid understanding of the drug development and clinical trial process, the role and workings of a Clinical Research Organisation (CRO), ICH GCP, international and local regulatory requirements.
Director Business Development-West Coast Frontage Clinical Services IncDirector Business Development-West CoastHayward, CA$120,000–$160,000 / yearOur core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. The focus of the role is new business development for pre-clinical / non-clinical toxicology and drug safety services in pharmaceutical drug development, and services including DMPK and related bioanalytical.
Clinical Development Scientist/Senior Clinical Development Scientist Tenvie TherapeuticsClinical Development Scientist/Senior Clinical Development ScientistBrisbane, CARemoteFull timeTenvie Therapeutics is seeking a scientifically rigorous and highly collaborative Clinical Scientist to support the design and execution of early clinical development programs across multiple indications including cardiometabolic and neuroinflammatory diseases. Lead or co‑lead the scientific design of Phase 1–2 studies (e.g., FIH, dose‑finding, PoC) including objectives, endpoints, inclusion/exclusion criteria, and biomarker strategy, Integrate nonclinical, translational, and clinical data to inform dose selection, schedule, and patient population.
Medical Director, Clinical Development (Oncology) Allogene Therapeutics IncMedical Director, Clinical Development (Oncology)South San Francisco, CARemote$255,000–$335,000 / yearEstablish cross-functional relationships with leaders from key cross-functional lines including Regulatory Affairs, Clinical Operations, Commercial, Program Management, etc. and leverage those relationships to manage key project issues including but not limited to Research, Development, Commercial, Manufacturing and Competitive Intelligence. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
NewMedical Director, Clinical Development (Oncology) Allogene TherapeuticsMedical Director, Clinical Development (Oncology)South San Francisco, CARemote$255,000–$335,000 / yearEstablish cross-functional relationships with leaders from key cross-functional lines including Regulatory Affairs, Clinical Operations, Commercial, Program Management, etc. and leverage those relationships to manage key project issues including but not limited to Research, Development, Commercial, Manufacturing and Competitive Intelligence. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.