About this role
Develop and execute ORIC’s global pharmacovigilance strategy in alignment with corporate objectives and applicable regulatory requirementsProvide leadership for benefit-risk evaluation, safety surveillance, signal detection, signal management, and risk management across ORIC’s investigational productsOwn all medical safety aspects of clinical development, including safety input into protocols, Investigator Brochures, clinical study reports, and regulatory submissionsLead 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 filingsServe as a senior safety advisor to the Chief Medical Officer and represent Pharmacovigilance in governance committees and safety review meetingsEstablish and evolve scalable pharmacovigilance systems, processes, quality frameworks, and vendor partnerships to support a growing oncology portfolioPartner with Clinical Development, Biostatistics, Regulatory Affairs, and Medical Affairs to lead and validate safety signal assessmentsCommunicate emerging safety information to appropriate stakeholders, including executive management and regulatory authorities, within timeframes appropriate to the benefit-risk profileBuild, 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-makingEnsure inspection readiness and compliance with global PV regulations, including leading root-cause analyses and CAPAs as neededManage relationships with PV vendors and CROs, providing expert safety oversight of outsourced operations MD, DO, PharmD, PhD, or equivalent advanced scientific/healthcare degree12+ years of progressive experience in pharmacovigilance, clinical safety, or drug development within the biotechnology or pharmaceutical industrySignificant experience leading and managing a pharmacovigilance or patient safety function or teamDemonstrated experience supporting investigational products across Phase 1-3 clinical developmentDeep knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH, and GCP requirementsExperience with safety governance, benefit-risk assessment, signal detection, risk management plans, and inspection readinessTrack record of successful health authority interactions and regulatory inspectionsExperience overseeing safety/PV vendors and CROsStrong strategic leadership, written and verbal communication, and cross-functional collaboration skillsAbility to operate with a high level of autonomy and sound judgment in a fast-paced, growth-stage environmentPreferred Experience:
Oncology drug development experience strongly preferredExperience supporting small molecule therapeuticsPrior experience preparing for or supporting commercial-stage pharmacovigilance activitiesExperience working in a global, outsourced operating model utilizing CROs and external PV vendors, ideally in a small to medium-sized corporate environmentDemonstrated success building, scaling, or evolving a pharmacovigilance organization at a growth-stage biotechExperience supporting regulatory submissions (IND/NDA/BLA) and post-marketing safety activities 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.