Senior Director, Head of Pharmacovigilance Operations

Build and lead the pharmacovigilance operations that carry Nurix's growing clinical portfolio toward commercialization. You'll own the end-to-end ICSR model, safety systems, vendor oversight, and inspection readiness, with the chance to set strategy while staying hands-on and to build the function and team from the ground up. Position Description The Opportunity Report to the Head of PV and define and execute the short- and long-term PVO strategy, goals, and operating model in alignment with the PV department and corporate objectivesGrow, mentor, and develop the PVO team, setting priorities and ensuring coverage across a growing portfolio; partner with the Head of PV on departmental planning, headcount, and budgetProvide PVO updates and escalate risks, issues, and compliance trends to PV and executive leadership as appropriateOversee the end-to-end ICSR management framework (intake, processing, in-stream quality review, regulatory submission oversight, and retrospective quality review), ensuring timeliness, accuracy, and compliance with global regulations (21 CFR, EU GVP, ICH E2 series)Define, monitor, and report case processing metrics (KPIs/KQIs), drive root cause analysis and resolution of quality or timeliness issues, and oversee the drug safety mailboxOversee SAE reconciliation with Clinical Operations and Data Management and Reference Safety Information (RSI) tracking and dissemination, and ensure PVO input into the safety content of clinical documents (protocols, ICFs, IBs/RSI, and CSRs)Ensure the integrity of safety data outputs from the Global Safety Database for aggregate reports, signal assessments, health authority requests, and other safety needsOversee operational delivery of aggregate safety reports (e.g., DSUR, PBRER/PSUR), and partner with Medical Safety, Regulatory Affairs, and Biostatistics to support signal management and benefit-risk evaluationOwn the strategy, validation, and lifecycle management of the Global Safety Database (e.g., Argus or equivalent) and related PV systems, including configuration, upgrades, and E2B gateway/electronic submissionLead system selection, implementation, and transition projects, including safety database migrations and vendor changes, and drive automation and process improvements such as reconciliation tools, intake portals, and reporting and analytics capabilitiesLead oversight of outsourced PV activities and the CROs and vendors that support them, establishing governance, KPIs/KQIs, scorecards, and performance reviews, and driving corrective actions when performance falls shortOwn PV budget planning, forecasting, and invoice review, identifying opportunities for cost optimization without compromising complianceLead the strategy and management of PV Agreements and Safety Data Exchange Agreements (SDEAs) with license partners, collaborators, and distributorsOwn PVO inspection readiness and launch readiness, and lead PVO participation in internal audits, vendor audits, and regulatory inspections, including front-room/back-room support and CAPA development and tracking through closureDevelop, maintain, and continuously improve PVO and compliance-related SOPs, work instructions, and process documentation, and monitor the evolving global regulatory landscape so PVO processes adapt to new requirementsAct as the senior PVO liaison to Clinical Operations, Data Management, Regulatory Affairs, Quality, Biostatistics, and Medical Safety, and support PV input into due diligence, in-licensing, and business development activities as needed What You’ll Bring Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field required; an advanced degree (PharmD, MS, PhD, MBA) is preferredMinimum of 12 years of pharmacovigilance/drug safety experience in biotech or pharma, including in a leadership role managing PV operations and peopleDeep experience in PV operations and ICSR management across clinical development, with commercial readiness experienceDemonstrated experience building, scaling, or transforming PV operations, ideally in a growing biotech environmentSignificant experience managing PV vendors and CROs, including KPI/KQI development, governance, and performance managementExperience owning PV budgets, forecasting, and invoicingExperience leading or substantially supporting regulatory inspections and audits (FDA, EMA, or other health authorities), including CAPA managementExperience with safety database implementations, upgrades, or transitionsProven experience authoring and governing SOPs, work instructions, and quality system documentationExperience negotiating and managing PVAs/SDEAs with license partnersStrong leadership, coaching, and talent development skills, with the ability to build high-performing teamsExcellent communication and influencing skills, with the ability to work effectively with executive leadership and cross-functional partnersStrong analytical, organizational, and project management skills, with the ability to manage multiple products and priorities at onceQuality and compliance mindset with strong attention to detailComfort operating in a fast-paced, evolving environment, including through organizational change Salary Range: $ $288,100 - $325,700 The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements. Location: Remote or Onsite – Brisbane, CA Fit with Nurix Culture and Values Strong team orientation; highly collaborativeSolutions and results-oriented focusHands-on approach; resourceful and open to diverse points of view About Nurix Therapeutics Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.