Senior Director, DSPV Gene Therapy Safety Lead

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

The Senior Director, DSPV Gene Therapy Safety Lead will be the safety expert for Insmed's gene therapy products and will maintain current knowledge of the assigned product portfolio and safety profiles for products. The Senior Director will be responsible for the day-to-day direction to ensure business needs and priority tasks are successfully 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 executing the safety and risk management activities. This individual is responsible for safety surveillance, risk management, and risk communication for assigned gene therapy development products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes. This role provides DSPV support for internal and external customers. This position reports to the Vice President, DSPV.

Responsibilities

• Leads the Safety Review Team(s) for assigned products and development compounds, and is responsible for the management of ongoing and cross functional assessment of benefit-risk profiles and related actions, including writing and updating 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). 
• 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. 
• Responsible for the delivery of high quality and timely medical safety outputs. 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. 
• Works with the VP, DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products. 
• Responsible for the writing of 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. 
• Leads the identification of risks and appropriate risk minimization and pharmacovig