Senior Director, DSPV Medical Safety

Insmed Inc. • Bridgewater, NJ • 3h 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 are seeking a highly experienced Senior Director, DSPV Medical Safety to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, DSPV, you'll be the medical expert for assigned products and maintain current knowledge of assigned product portfolio and safety profiles. This individual will provide the day-to-day direction to the Medical Safety Team to ensure business needs and priority tasks are efficiently completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety surveillance, risk management, and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports and safety documents, including labeling changes.What You'll Do: In this role, you'll have the opportunity to lead strategic consultation and guidance to the PV scientists on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, evaluation, interpretation and appropriate management and communication of safety information for Insmed's portfolio of products in development. You'll also: Be responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds. Deliver high quality and timely medical safety deliverables and provide content and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee. 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 for assigned products and development compounds. 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 ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products. Lead the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, Company Core Data Sheet, Investigator's Brochure and Risk Management Plans (RMPs), and Risk-Evaluation and Mitigation Strategies (REMS). Prepare responses to inquiries from regulatory authorities on safety issues for assigned products and lead the integrated safety input into all regulatory documents where required. * Maintain and evaluate Medical Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, creating an action plan, and c

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