Senior Executive Director, Pharmacovigilance

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $250k - $330k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 1%

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• Serve as Head of Pharmacovigilance, accountable for safety strategy, safety science, and PV operations across the portfolio • Report to the Chief Medical Officer • Build a fit-for-purpose, inspection-ready PV function that scales with JADE101 global Phase 3 development and JADE201/JADE301 early development • Establish safety governance and signal management frameworks • Oversee outsourced PV vendors and author or review key safety deliverables • Partner with Clinical Development, Regulatory Affairs, Clinical Operations, Biometrics, Quality, and Program Management • Ensure timely, compliant expedited and periodic reporting, including SUSARs, IND safety reports, and DSURs, to FDA, EMA, and other health authorities • Author or provide senior review of safety content for protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and health authority responses • Support global expansion, including Japanese and Chinese regulatory interactions and multi-region Phase 3 execution • Oversee safety database management, case processing, reconciliation, literature screening, and submissions • Own vendor KPIs, quality metrics, PV budget, and resourcing model • Negotiate and implement safety data exchange agreements with partners, licensors, and CROs • Build and maintain PV quality systems, SOPs, work instructions, training curricula, and PV system master file • Ensure GVP/GCP compliance and lead PV inspection- and audit-readiness activities with Quality Assurance • Identify and close process gaps during transition from early- to late-stage development • Hire, mentor, and develop PV staff and consultants; establish scalable processes and a culture of scientific rigor and accountability

🎯 Requirements

• Bachelor’s degree with 10–15 years of industry experience • Minimum of 10 years of pharmacovigilance/drug safety experience in the biopharmaceutical industry • Progressive leadership responsibility; Executive Director level requires broader scope and prior head-of-function experience • Demonstrated experience as head of PV or deputy in a development-stage company • Experience building fit-for-purpose PV processes and quality systems • Deep working knowledge of global PV regulations and guidance, including 21 CFR, ICH E2A/E2B/E2C/E2D/E2F, and EU GVP modules • Knowledge of expedited and aggregate reporting requirements • Experience selecting and overseeing PV vendors, safety databases such as Argus, and outsourced case processing operations • Experience supporting FDA and/or EMA health authority inspections and client/sponsor audits with successful outcomes • Excellent scientific judgment, written and verbal communication, and cross-functional collaboration skills • Preferred: 10 years of experience with biologics/monoclonal antibodies and immunology, rheumatology, nephrology, or rare disease programs • Preferred: Experience supporting late-stage global development and BLA/MAA safety deliverables, including risk management plans • Preferred: Familiarity with safety data visualization and analytics tools for signal detection • Preferred: Experience integrating PV requirements across licensing/partnering relationships • Preferred: Prior experience scaling a PV function from first-in-human through Phase 3 and toward marketing authorization • Authorization to work in the United States as verified through I-9 and E-Verify

🏖️ Benefits

• Remote work arrangement • Periodic travel to team and company events