Director, Medical Safety Lead - DSPV, Gene Therapy

Insmed Inc. • Bridgewater, NJ • 6h ago

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:We're looking for a Director, Medical Safety Lead - DSPV Gene Therapy to help us expand what's possible for patients with serious diseases. Reporting to the Sr Director, DSPV Gene Therapy Safety Lead, the Director, Medical Safety Lead serves as the DSPV subject matter expert for assigned products, maintaining deep and up-to-date knowledge of the product portfolio and associated safety profiles.This role is responsible for safety surveillance, risk management, and risk communication across assigned development and marketed products. It includes medical evaluation of individual adverse event reports, oversight of aggregate report generation and safety documentation, and collaboration on labeling updates. The position also provides expert DSPV support to both internal and external stakeholders.What You'll Do: In this role, you'll have the opportunity to review all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds. You'll also: Conduct safety signal detection activities, monitoring, evaluation, interpretation, and appropriate management and communication of safety information. Lead the Safety Review Team(s) for assigned products and development compounds and manage the ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents. Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs). Work with the DSPV leadership to develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products. Provide input into the writing of periodic reports for assigned products; provide medical interpretation, review, and approval for required reports. Share DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal. Provide expert safety input to the clinical development program for assigned products and development compounds. Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds. Provide integrated safety input into all regulatory documents, thorough assessment of safety profiles for Due Diligence projects, and provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters. Respond to inquiries from regulatory authorities on safety issues.Who You Are:You must have an MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance within a pharmaceutical industry setting across both investigational and marketed products. Additionally, you have: Experience reviewing and preparing scientific or regulatory documents from large volumes of scientific information. Knowledge and understanding of national & international Pharmacovigilance and

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