[Hiring] Director, Medical Safety @Insmed Incorporated

Role Description

We’re looking for a Director, Medical Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll oversee a team of Pharmacovigilance (PV) Scientists responsible for signal detection, risk management, aggregate safety reporting, and clinical trial safety support.

• Ensure the delivery of high-quality safety surveillance activities throughout the product lifecycle while maintaining compliance with global pharmacovigilance regulations and company procedures.
• Serve as a strategic partner to Medical Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, and Quality Assurance.
• Ensure timely identification, assessment, and communication of product safety risks.

Qualifications

• Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline.
• 10 years of experience in the pharma/biotech industry.
• Minimum of 5 years of direct people management experience leading PV Scientists or Medical Safety professionals.

Requirements

• Demonstrated experience supporting both clinical development and post-marketing pharmacovigilance activities.
• Extensive experience in signal detection and signal management.
• Experience with safety databases (e.g., Argus, ARISg) and safety analytics tools is preferred.
• Strong understanding of benefit-risk assessment methodologies.
• Exceptional experience authoring and managing Risk Management Plans (RMPs), aRMM and REM.
• Significant experience preparing and overseeing aggregate safety reports (DSURs, PSURs/PBRERs, Annual Reports).
• Experience supporting clinical studies throughout the product development lifecycle.
• Thorough knowledge of ICH guidelines, FDA, EMA, and global pharmacovigilance regulations.
• Excellent leadership with strong scientific and analytical skills.
• Strategic thinker with strong project management skills.
• Ability to influence cross-functional stakeholders and PV senior leadership.
• Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.
• Demonstrated commitment to quality, compliance, and continuous improvement.
• Exceptional written and verbal communication skills.
• Strong understanding of AI, automation, and advanced analytics applications within pharmacovigilance and drug safety.
• Proven ability to evaluate and implement innovative technologies that improve operational efficiency, data quality, and regulatory compliance.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP).
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• Company-paid life and disability insurance.
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.