Director, Medical Safety Lead - DSPV, Gene Therapy
Insmed Incorporated
August 20, 2026
Remote
United States
Medical Affairs
About The Role
Director, Medical Safety Lead - DSPV Gene Therapy. Reporting to Sr Director, DSPV Gene Therapy Safety Lead. Serves as DSPV subject matter expert for assigned products, maintaining up-to-date knowledge of product portfolio and safety profiles.
Responsibilities / What You’ll Do
- Review safety data across pre-clinical, clinical, post-marketing, and literature for assigned products/development compounds.
- Conduct safety signal detection; monitor, evaluate, interpret, and manage/communicate safety information.
- Lead Safety Review Team(s); assess benefit-risk profiles and actions; write/update benefit-risk documents.
- Provide medical expert safety input to clinical development documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Develop safety and benefit-risk management strategy; develop Risk Management content (RMPs, REMS).
- Contribute to periodic reports; provide medical interpretation/review/approval.
- Collaborate with global functions (Clinical Development, Regulatory Affairs, QA, Medical Affairs, Marketing, Manufacturing, Legal).
- Ensure accurate safety profile representation/communication in labeling with Regulatory Affairs.
- Provide integrated regulatory safety input for Due Diligence, recalls, Health Hazard Evaluations, and Dear HCP letters.
- Respond to regulatory authority inquiries on safety issues.
Qualifications
- MD or DO with 5+ years Drug Safety/Pharmacovigilance in pharma (investigational and marketed products).
- Experience preparing/reviewing scientific or regulatory documents; knowledge of national/international PV and regulatory guidelines.
- Experience presenting to regulatory authorities/at conventions.
- Strong verbal/written communication and organizational skills; attention to detail.
Nice to Have
- MPH; 2+ years clinical patient care; drug safety database knowledge; gene therapy experience; product defense experience.
Benefits (U.S.)
- Medical/dental/vision, mental health support, EAP; paid time off; fertility/family-forming benefits/caregiver support; 401(k) match, annual equity, ESPP; company-paid life/disability; learning/mentorship; employee resource groups.
Application Instructions
Current Insmed employees: apply via Jobs Hub in Workday.
Director, Medical Safety Lead - DSPV Gene Therapy. Reporting to Sr Director, DSPV Gene Therapy Safety Lead. Serves as DSPV subject matter expert for assigned products, maintaining up-to-date knowledge of product portfolio and safety profiles.
Responsibilities / What You’ll Do
- Review safety data across pre-clinical, clinical, post-marketing, and literature for assigned products/development compounds.
- Conduct safety signal detection; monitor, evaluate, interpret, and manage/communicate safety information.
- Lead Safety Review Team(s); assess benefit-risk profiles and actions; write/update benefit-risk documents.
- Provide medical expert safety input to clinical development documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Develop safety and benefit-risk management strategy; develop Risk Management content (RMPs, REMS).
- Contribute to periodic reports; provide medical interpretation/review/approval.
- Collaborate with global functions (Clinical Development, Regulatory Affairs, QA, Medical Affairs, Marketing, Manufacturing, Legal).
- Ensure accurate safety profile representation/communication in labeling with Regulatory Affairs.
- Provide integrated regulatory safety input for Due Diligence, recalls, Health Hazard Evaluations, and Dear HCP letters.
- Respond to regulatory authority inquiries on safety issues.
Qualifications
- MD or DO with 5+ years Drug Safety/Pharmacovigilance in pharma (investigational and marketed products).
- Experience preparing/reviewing scientific or regulatory documents; knowledge of national/international PV and regulatory guidelines.
- Experience presenting to regulatory authorities/at conventions.
- Strong verbal/written communication and organizational skills; attention to detail.
Nice to Have
- MPH; 2+ years clinical patient care; drug safety database knowledge; gene therapy experience; product defense experience.
Benefits (U.S.)
- Medical/dental/vision, mental health support, EAP; paid time off; fertility/family-forming benefits/caregiver support; 401(k) match, annual equity, ESPP; company-paid life/disability; learning/mentorship; employee resource groups.
Application Instructions
Current Insmed employees: apply via Jobs Hub in Workday.