Associate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance) Arrowhead PharmaceuticalsAssociate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance)San Diego, CA$180,000–$230,000 / yearThe Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department. 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.
Associate Director/Director, Drug Safety & Pharmacovigilance Quality & Compliance Arrowhead Pharmaceuticals IncAssociate Director/Director, Drug Safety & Pharmacovigilance Quality & ComplianceSan Diego, CA$180,000–$230,000 / yearThe Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department. 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.
Associate Director/Director, Quality & Compliance Drug Safety & Pharmacovigilance Arrowhead Pharmaceuticals IncAssociate Director/Director, Quality & Compliance Drug Safety & PharmacovigilanceSan Diego, CAThe Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department. Proactively provide Good Pharmacovigilance Practice (GVP) support for clinical, post marketing and commercial activities including PV/ safety systems to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems.
Director, Drug Safety & Pharmacovigilance Xencor IncDirector, Drug Safety & PharmacovigilanceSan Diego, CARemote$206,000–$255,000 / yearProvides end to end Drug Safety/PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual core product document updates (IB, ICF), and CSR authoring as well as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions.
Senior Director of Drug Safety XtalPi IncSenior Director of Drug SafetySan Diego, CAWorking at the interface of computational design, translational biology and preclinical development, you will integrate mechanistic toxicology, pharmacology, DMPK and emerging clinical insights to enable informed, data-driven programme decisions and successful human translation. Reporting to the VP, Head of In Vivo Bioscience, the role will shape nonclinical and translational safety strategies supporting the progression of novel biologics, multi-specific antibodies and peptide therapeutics from discovery through early clinical development.
Director, Drug Safety & Pharmacovigilance - Safety Scientist Travere Therapeutics IncDirector, Drug Safety & Pharmacovigilance - Safety ScientistSan Diego, CARemote$189,000–$246,000 / yearWe stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Principal Scientist, Nonclinical Drug Safety Program Discovery Merck & Co IncPrincipal Scientist, Nonclinical Drug Safety Program DiscoverySan Diego, CA$176,200–$277,300 / yearThey are responsible for 1) providing risk assessments for targets, 2) de-risking strategies for discovery programs and 3) collaborating with NDS staff at other sites to execute on the appropriate studies to support selection of therapeutic targets, and the identification and development of new drug candidates. The Discovery Program Leader is responsible for defining and overseeing the NDS strategy for programs in all modalities (including small molecules, peptides, biologics and ADC programs) from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies.
Senior Drug Safety and Pharmacovigilance Specialist Travere Therapeutics IncSenior Drug Safety and Pharmacovigilance SpecialistSan Diego, CA$95,000–$124,000 / yearWe stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Associate Engineering Director, Combination Drug Product/Device Neurocrine Biosciences IncAssociate Engineering Director, Combination Drug Product/DeviceSan Diego, CA$173,600–$237,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. About the Role: In partnership with the broader CMC organization, the Associate Director of Drug/Device Combination Products will lead the development and lifecycle strategy for drug/device combination products, including prefilled syringe and autoinjector presentations.
Sr. Research Associate, Drug Product Development Crinetics Pharmaceuticals IncSr. Research Associate, Drug Product DevelopmentCA$82,000–$103,000 / yearPosition Summary: The Senior Research Associate, Drug Product Development, will support the development of drug product formulations from early preclinical enabling studies through clinical supply for First-in-Human (FIH) trials. The position works closely with formulation scientists, analytical, DMPK, toxicology, and manufacturing teams to deliver high quality drug products in a fast-paced development environment.
DRUG-GEN MDSE/CLERK RalphsDRUG-GEN MDSE/CLERKEncinitas, CAPart timeA wide range of healthcare coverage, including affordable, comprehensive medical, dental, vision and prescription coverage, through company plans or collective bargaining agreement plans. Create an environment that enables customers to feel welcome, important and appreciated by answering questions regarding products sold within the department and throughout the store.
Drug Product Manufacturing Associate I - Formulations 1st and 2nd Shift PCI Pharma ServicesDrug Product Manufacturing Associate I - Formulations 1st and 2nd ShiftSan Diego, CA$21.69–$24.41 / hourExpected to operate production equipment, including the TFF system, Rotavap, Microfluidizer, Homogenizer, chiller, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven, and CIP system. Works closely with Production Planner to manage QAD work orders and ensure production materials are obtained according to the manufacturing schedule.
DRUG-GEN MDSE/CLERK Kroger Co.DRUG-GEN MDSE/CLERKSan Diego, CAPart timeA wide range of healthcare coverage, including affordable, comprehensive medical, dental, vision and prescription coverage, through company plans or collective bargaining agreement plans. Create an environment that enables customers to feel welcome, important and appreciated by answering questions regarding products sold within the department and throughout the store.
Senior Director, Safety and Pharmacovigilance (PV) Artiva Biotherapeutics IncSenior Director, Safety and Pharmacovigilance (PV)San Diego, CA$265,000–$280,000 / yearArtiva 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. 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 Sjögrens Disease as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.
Safety Medical Director Zentalis Pharmaceuticals IncSafety Medical DirectorSan Diego, CAEDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED: MD with 8-12 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.•Strong understanding of pharmacovigilance regulations in the US and EU.•Experience in supporting drug safety activities in registrational clinical studies•Demonstrated skills in scientific analysis and reasoning.•Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.•Prior Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes.
Director, Safety Science Arrowhead PharmaceuticalsDirector, Safety ScienceSan Diego, CA$240,000–$260,000 / yearArrowhead 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. Review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event (SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations).
Director, Safety Science Arrowhead Pharmaceuticals IncDirector, Safety ScienceSan Diego, CA$240,000–$260,000 / yearArrowhead 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. Review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event (SAE) reporting forms, Clinical Study Reports, and Investigator''s Brochures (including Reference Safety Information determinations).
Associate Director, Global Safety Lead - Remote Agios PharmaceuticalsAssociate Director, Global Safety Lead - RemoteSan Diego, CARemote$185,369–$308,948 / yearo The current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. • Proactively assesses and evaluates the clinical implications of safety data from all sources in order to understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing settings as appropriate.
Senior Director, Medical Monitor & Safety Physician Travere Therapeutics IncSenior Director, Medical Monitor & Safety PhysicianSan Diego, CARemote$233,000–$315,000 / yearThis role delivers hands on medical monitoring, supports benefit risk evaluation, and contributes to safety strategy execution in close partnership with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory, Biostatistics, and other cross functional teams. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
CLINICAL SOCIAL WORKER (HEALTH/CORRECTIONAL FACILITY) - SAFETY State Of CaliforniaCLINICAL SOCIAL WORKER (HEALTH/CORRECTIONAL FACILITY) - SAFETYSan Diego, CA$8,678–$10,569 / yearUnder the general direction of the Senior Psychologist, Correctional Facility (CF) (Supervisor) or the Supervising Psychiatric Social Worker, CF, the Clinical Social Worker (Health/CF) Safety, conducts assessments and summarizes case information to use in diagnosis, treatment (level of care), and dispositional release; diagnoses and/or collaborates in the formulation of a diagnosis; develops, monitors, and modifies treatment plans in collaboration with the interdisciplinary treatment team. [Unlicensed individuals who are recruited from outside the State of California and who qualify for licensure may take the examination and may be appointed for a maximum of one year at which time licensure shall have been obtained or the employment shall be terminated; an extension of the waiver may be granted for an additional one year based on extenuating circumstances, as provided by Section 1277(e) of the Health and Safety Code.
Paramedic (Non-Safety) City of Chula Vista, CAParamedic (Non-Safety)Chula Vista, CA$75,678–$92,019 / yearAbility to: perform competently under extreme pressure and in stressful situations; make accurate observations and rapid judgments; learn new skills and methods quickly and accurately; work in a variety of weather conditions (hot, cold, rain, wind, dust, etc.) and in extremely hazardous situations; work 24-hour shifts, weekends and holidays; work variable shifts and overtime, as required; perform life saving techniques to victims; maintain and participate in continuing education (CE) requirements associated with a paramedic license/accreditation with the State of California and County of San Diego; learn and follow City policies and procedures; learn and follow Fire Department rules and regulations; read and understand printed information during emergency calls; follow written and verbal orders from supervisors; work effectively as a team member of a company, battalion, department, and/or special project groups by following orders, consistently following through with duties/assignments and living harmoniously with co-workers; attend meetings and training activities; communicate clearly and concisely, both orally and in writing; operate, maintain, inspect and repair vehicles, apparatus and equipment; clean and maintain fire station and grounds; teach classes and participate in public education demonstrations and activities; operate computer related equipment and software applications related to assignment; write comprehensive reports and maintain accurate records; wear approved uniform; establish and maintain effective working relationships with those contacted in the course of work; work with various cultural and ethnic groups in a tactful and effective manner. In addition to providing emergency medical response and firefighting services to citizens, the Fire Department also provides technical rescue training to first responders across the country, comprehensive fire safety engineering plan review and inspection services to Chula Vistas business community, and provides fire and life safety education and outreach to City residents.
Sr. Specialist, Health and Safety Programs Neurocrine Biosciences IncSr. Specialist, Health and Safety ProgramsSan Diego, CA$97,000–$133,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids , as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. Your Contributions (include, but are not limited to): Provide coaching and support to functional areas, project teams, and/or employees on health and safety policies, procedures, and other H&S guidance, including monitoring compliance, performance indicator tracking and/or reporting within the area of support and promoting, reinforcing, and sustaining a strong safety culture through engagement with leadership and teams.
Vice President, Pharmacovigilance Vera Therapeutics IncVice President, PharmacovigilanceSan Diego, CA$300,000–$420,000 / yearVera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Working with the internal stakeholders across Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, and Commercial functions to integrate safety strategy throughout the product lifecycle this role will provide strategic and tactical leadership and oversee all aspects of Pharmacovigilance activities through all stages of clinical development as well as post-marketing patient safety.
Associate Director/Director, Pharmacovigilance Compliance Arrowhead PharmaceuticalsAssociate Director/Director, Pharmacovigilance ComplianceSan Diego, CA$180,000–$230,000 / yearThe Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department. 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.
Senior Manager, Pharmacovigilance ORIC Pharmaceuticals IncSenior Manager, PharmacovigilanceSan Diego, CA$150,000–$180,000 / yearORIC'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. The Senior Manager of Pharmacovigilance will be responsible for the execution of global pharmacovigilance activities supporting late-stage clinical development and preparation for first commercial launch of small-molecule oncology products in lung and prostate cancer.
Senior Pharmacovigilance Associate Allen SpoldenSenior Pharmacovigilance AssociateLa Jolla, CaliforniaAccountable for multiple tasks including CAPA, ICSR reconciliation, database interfaces, single case compliance, external and internal stakeholder correspondence, and prioritizes tasks according to designated criteria. Demonstrates strong teamwork skills to ensure that processes, procedures, and best practices are consistent across GPV&E and that regulatory requirements are met in a timely manner and with high quality.
Medical Director MD, Clinical Development, Endocrinology Neurocrine Biosciences IncMedical Director MD, Clinical Development, EndocrinologySan Diego, CA$254,600–$347,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids , as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. Requirements: MD or DO degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required AND 2+ years of experience in clinical research and development (Phase 1-4) in either a pharmaceutical/biotechnology company or a clinical research/academic environment or related experience required.
Associate Medical Director Zentalis Pharmaceuticals IncAssociate Medical DirectorSan Diego, CAFocused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. The position contributes to signal detection activities, literature review, and operational pharmacovigilance processes, while collaborating with cross-functional teams and providing support to senior safety physicians.
Associate Director, Medical Review Lead, MSRM - Remote Agios PharmaceuticalsAssociate Director, Medical Review Lead, MSRM - RemoteSan Diego, CARemote$185,369–$308,948 / yearThe current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This role provides oversight of medical review for Individual Case Safety Reports (ICSRs) across investigational and marketed products, ensuring medical accuracy, regulatory compliance, and high-quality safety data to support pharmacovigilance and risk management activities.
NewDirector, Clinical QA Neurocrine Biosciences IncDirector, Clinical QASan Diego, CA$181,800–$248,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids , as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. Responsible for building and leading a team of highly trained and skilled quality managers, specialists and associates in order to implement the quality systems and perform activities necessary to ensure compliance and to ensure QA support of clinical study teams.
Medical Director Keros Therapeutics IncMedical DirectorSan Diego, CAPrimary ResponsibilitiesMedical and Scientific Oversight for Clinical TrialsProvide medical leadership and expertise to cross-functional study teams, guiding the clinical development of one or more neuromuscular and/or neurology programs. A genuine interest in learning and understanding the science supporting the pipeline, an ability to work collaboratively in a highly matrixed multidisciplinary team setting, and a commitment to developing new treatments for patients in need are critical for success in this role.
Associate Director, Clinical Operations Artiva Biotherapeutics IncAssociate Director, Clinical OperationsSan Diego, CA$190,000–$200,000 / yearExperience in Cell Therapy, Autoimmune or Rare Disease is strongly preferred A minimum of 10 years' relevant industry experience, including CRO/vendor management, with expertise in clinical operations leading early through late-stage clinical trials Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations. 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 Sjögren's Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.
Director, Pharmacovigilance Cabaletta Bio IncDirector, PharmacovigilanceSan Diego, CACross-Functional Collaboration Partner closely with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs to ensure integrated safety oversight across programs. Contribute to the development and maintenance of safety-related documents, including DSURs, IBs, protocols, and safety sections of regulatory submissions (e.g., INDs/BLAs).
Manager/Sr. Manager, Clinical GCP Quality Assurance Rakuten Medical IncManager/Sr. Manager, Clinical GCP Quality AssuranceSan Diego, CA$150,000–$170,000 / yearOur first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Sr. Clinical Program Manager Neurocrine Biosciences IncSr. Clinical Program ManagerSan Diego, CA$156,900–$214,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids , as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. Interact with all program stakeholders including Clinical Operations, Drug Safety and Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, and Regulatory departments to ensure alignment on Clinical program goals, timelines, and resources required.
Vice President, Clinical Development Travere Therapeutics IncVice President, Clinical DevelopmentSan Diego, CARemote$305,000–$412,000 / yearAdditional responsibilities include developing relationships with leading key opinion leaders, acting as subject matter expert for additional programs, providing medical support as needed for clinical trials, marketed products, pharmacovigilance, as well as providing medical/scientific expertise as needed for business development efforts. This accomplished and experienced clinical leader will work collaboratively with all functions as the Global Development Physician Lead on the Program Strategy Teams (PST) to develop and deliver a clinical development strategy tailored RKD programs, which are efficient and of high scientific quality.