Vice President, Pharmacovigilance and Drug Safety (Head of Pharmacovigilance and Drug Safety)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. ORIC Pharmaceuticals is seeking an experienced Pharmacovigilance and Drug Safety expert to lead the company's global drug safety and pharmacovigilance function. This executive will be accountable for patient safety, including safety surveillance, signal detection, and risk management, as well as regulatory compliance, and benefit-risk assessment across ORIC's oncology portfolio in clinical development. The VP will also oversee Pharmacovigilance Operations and partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Technical Operations to build and maintain a compliant, inspection-ready global PV system as ORIC advances its pipeline toward late-stage development. This individual will serve as a key safety representative for ORIC's programs, mentor cross-functional colleagues, and help strengthen safety science processes and patient safety practices as the company advances toward late-stage development.
Job Description:- Develop and execute ORIC's global pharmacovigilance strategy in alignment with corporate objectives and applicable regulatory requirements
- Provide leadership for benefit-risk evaluation, safety surveillance, signal detection, signal management, and risk management across ORIC's investigational products
- Own all medical safety aspects of clinical development, including safety input into protocols, Investigator Brochures, clinical study reports, and regulatory submissions
- Lead the strategy for and drive safety-related content for protocols, Investigator Brochures, DSURs, PSURs, risk management plans, informed consent forms, reference safety information, clinical study reports, and regulatory filings
- Serve as a senior safety advisor to the Chief Medical Officer and represent Pharmacovigilance in governance committees and safety review meetings
- Establish and evolve scalable pharmacovigilance systems, processes, quality frameworks, and vendor partnerships to support a growing oncology portfolio
- Partner with Clinical Development, Biostatistics, Regulatory Affairs, and Medical Affairs to lead and validate safety signal assessments
- Communicate emerging safety information to appropriate stakeholders, including executive management and regulatory authorities, within timeframes appropriate to the benefit-risk profile
- Build, develop, and mentor a high-performing pharmacovigilance team, across both medical and operations functions, fostering a culture of scientific rigor, accountability, and patient-centered decision-making
- Ensure inspection readiness and compliance with global PV regulations, including leading root-cause analyses and CAPAs as needed
- Manage relationships with PV vendors and CROs, providing expert safety oversight of outsourced operations
Qualifications:- MD, DO, PharmD, PhD, or equivalent advanced scientific/healthcare degree 12+ years of progressive experience in pharmacovigilance, clinical safety, or drug development within the biotechnology or pharmaceutical industry
- Significant experience leading and managing a pharmacovigilance or patient safety function or team
- Demonstrated experience supporting investigational products across Phase 1-3 clinical development
- Deep knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH, and GCP requirements
- Experience with safety governance, benefit-risk assessment, signal detection, risk management plans, and inspection readiness
- Track record of successful health authority interactions and regulatory inspections
- Experience overseeing safety/PV vendors and CROsStrong strategic leadership, written and verbal communication, and cross-functional collaboration skills
- Ability to operate with a high level of autonomy and sound judgment in a fast-paced, growth-stage environment
Preferred Experience:- Oncology drug development experience strongly preferred
- Experience supporting small molecule therapeutics
- Prior experience preparing for or supporting commercial-stage pharmacovigilance activities
- Experience working in a global, outsourced operating model utilizing CROs and external PV vendors, ideally in a small to medium-sized corporate environment
- Demonstrated success building, scaling, or evolving a pharmacovigilance organization at a growth-stage biotech
- Experience supporting regulatory submissions (IND/NDA/BLA) and post-marketing safety activities
Additional Information:
The anticipated base salary for Vice President level candidates who will work on-site at our San Diego location is between $310,000-$385,000 per year. The final rate 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. This position is not eligible for H-1B visa sponsorship. 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.
