Executive Director, Medical Safety Strategy and Benefit Risk Management

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 Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed’s investigational and marketed products while spearheading the integration of new technology and processes to enhance patient safety and benefit risk management. The ED will provide day-to-day leadership and guidance to the Medical Safety Strategy and Benefit-Risk Management group within DSPV to ensure timely delivery of high priority tasks in accordance with all relevant company and regulatory policies and procedures. This role also oversees global safety and risk management activities for Insmed’s portfolio with a focus on proactive signal detection, signal management, and benefit-risk evaluations ensuring strategic alignment throughout the product’s lifecycle. This position reports to the VP, DSPV and may serve as delegate during his absence.

Responsibilities

Responsibilities and job scope: 

• Lead the DSPV Medical Safety Strategy and Benefit-Risk Management group providing strategic direction, oversight and leadership across all activities including the ongoing and cross functional assessment of benefit risk profiles for development compounds and marketed products.
• Provide high level strategic consultation and subject matter expertise on decisions with significant safety impact including safety signal detection, evaluation, validation, escalation, and communication for Insmed’s portfolio.
• Ensure effective monitoring and proactive management of medical safety deliverables.
• Provide medical review, scientific content input, and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee.
• Provide strategic leadership in the advancement of global medical safety operations in alignment with strategic safety objectives and operational excellence functions.
• Provide medical expert safety review input into all critical documents for clinical development of products including protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, and CTAs ensuring safety content is clear, accurate, and compliant.
• Lead the analysis and interpretation of safety data for inclusion in regulatory submissions and marketing applications in partnership with Clinical Development and other relevant functions. This includes NDA/MAA safety sections, reference safety information (i.e, CCDS), PSUR/PBRER, DSUR, as well as scientific publications, abstracts, and presentation materials.
• Lead the development and ongoing review of Risk Management Plans (RMPs), Risk-Evaluation and Mitigation Strategies (REMS), and other PV tools that support Regulatory Compliance and patient safety.
• Responsible for the preparation of responses to safety-related inquiries from regulatory authorities; provide guidance and final review of submissions authored by other Medical Safety Leads.
• Develop, track, and report on critical metrics and quality indicators, identifying trends and implementing corrective and preventative actions.
• Oversee medical safety and pharmacovigilance ac