Senior Executive Director, Pharmacovigilance

Jade Biosciences

3d•$250,000 - $330,000•Remote

About The Position

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn. Jade Biosciences is seeking an experienced pharmacovigilance leader to serve as the Company's Head of Pharmacovigilance, with accountability for safety strategy, safety science, and PV operations across the portfolio. Reporting to the Chief Medical Officer, this individual will build a fit-for-purpose, inspection-ready PV function designed to scale as JADE101 advances into global Phase 3 and as JADE201 and JADE301 progress through early development. This is a hands-on, build-oriented role in a lean organization. The successful candidate will operate as both strategist and practitioner — setting safety governance and signal management frameworks while personally overseeing outsourced PV vendors, authoring and reviewing key safety deliverables, and partnering closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biometrics, and Quality. The role may be filled at the Senior Director or Executive Director level depending on experience and scope.

Requirements

Bachelor’s with 10-15 years of industry experience with a minimum of 10 years of pharmacovigilance/drug safety experience in the biopharmaceutical industry, with 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, including building fit-for-purpose PV processes and quality systems.
Deep working knowledge of global PV regulations and guidance (21 CFR, ICH E2A/E2B/E2C/E2D/E2F, EU GVP modules) and of expedited and aggregate reporting requirements.
Proven track record of PV vendor selection and oversight, including safety database (e.g., Argus) and outsourced case processing operations.
Experience supporting health authority inspections (FDA and/or EMA) and client/sponsor audits with successful outcomes.
Excellent scientific judgment, written and verbal communication, and cross-functional collaboration skills.

Nice To Haves

10 years of experience with biologics/monoclonal antibodies and with immunology, rheumatology, nephrology, or rare disease programs.
Experience supporting late-stage global development and BLA/MAA safety deliverables, including risk management plans.
Familiarity with safety data visualization and analytics tools to support signal detection.
Experience integrating PV requirements across licensing/partnering relationships.
Prior experience scaling a PV function from first-in-human through Phase 3 and toward marketing authorization.

Responsibilities

Ensure timely, compliant expedited and periodic reporting (SUSARs, IND safety reports, 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 safety requirements associated with Japanese and Chinese regulatory interactions and multi-region Phase 3 execution.
Provide strategic and day-to-day oversight of outsourced PV service providers, including safety database management, case processing, reconciliation, literature screening, and submissions.
Own vendor performance management, KPIs, and quality metrics; manage the PV budget and resourcing model.
Negotiate and implement safety data exchange agreements (SDEAs/PVAs) with partners, licensors, and CROs.
Build and maintain a right-sized PV quality system, including SOPs, work instructions, training curricula, and the PV system master file as applicable.
Ensure ongoing GVP/GCP compliance and lead PV inspection- and audit-readiness activities with Quality Assurance.
Identify and close process gaps proactively as the organization transitions from early- to late-stage development.
Partner with Clinical Development, Regulatory, Clinical Operations, Biometrics, Quality, and Program Management as the PV representative on program and development teams.
Hire, mentor, and develop PV staff and consultants as the function grows; establish scalable processes and a culture of scientific rigor and accountability.