Senior Director, DSPV Medical Safety

Insmed Inc. • Bridgewater, NJ • 1d 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 four 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:The Senior Director is the DSPV medical expert for assigned products and maintains 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. This role provides DSPV support for internal and external customers.This position reports to the Executive Director (ED), DSPV and will provide coverage for the ED, DSPV during his absence.What You'll Do: Leads 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. 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. Delivers high quality and timely medical safety deliverables. Provides content and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee. Responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information. Leads the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of 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. Provides 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). Works with the ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products. Delivers key content of Risk Management documents (RMPs, REMS) of assigned products. Writes periodic reports for assigned products; provides medical interpretation, review, and approval for required reports. Shares 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. Provides expert safety input to the clinical development program for assigned products and development compounds Leads the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develops/provides input to prod

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