Executive Medical Director, Patient Safety (Hybrid)
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Medical Affairs
General Summary:
Oversee all safety and benefit-risk related activities for Vertex Global Patient Safety (GPS), including DASH/DST and Aggregate Report Risk Management (ARRM) groups. Ensure consistency and compliance in safety assessment, analysis, and reporting across designated product(s) worldwide, including pre-marketing risk assessment, FIH planning, regulatory submission safety content, and development/execution of RMPs and/or REMS.
Key Duties and Responsibilities:
- Provide leadership/oversight of DASH/DST conduct, including pre-FIH benefit-risk assessment and strategy.
- Coordinate timely review of safety data to identify new safety signals.
- Develop and implement product risk management procedures/plans pre- and post-approval.
- Lead safety content for regulatory authority documents (SCS, CLO, Labelling) and development of REMS/RMP/equivalents.
- Collaborate on pharmacoepidemiology studies as needed.
- Review/assist with DSURs, PSURs/PBRERs, IND packages, and NDA/INDs.
- Provide safety input for labeling (IB, CCDS, USPI, SmPC, local labels).
- Provide responses to safety-related regulatory inquiries.
- Oversee medical review of adverse event reports and evaluate other non-AE/SAE safety information (toxicology, non-clinical, product quality).
- Oversee safety sections/content in key study and clinical reports (protocols, SAP, IB, ICF, IDMC charter, CSRs).
- Serve as subject matter expert for SOP/work instruction development; lead medical staff and develop direct reports.
Knowledge and Skills:
- Extensive knowledge of GCP, ICH, and global regulations.
- In-depth general medicine knowledge.
- Strong matrix leadership and communication.
- Ability to critically evaluate/interprete data and synthesize clear messaging.
- Extensive benefit-risk strategy/decision-making.
- Ability to multi-task.
Education and Experience:
- MD/DO (or equivalent ex-US medical degree).
- 12+ years pharmacovigilance experience and 7+ years supervisory/management experience (or equivalent).
Oversee all safety and benefit-risk related activities for Vertex Global Patient Safety (GPS), including DASH/DST and Aggregate Report Risk Management (ARRM) groups. Ensure consistency and compliance in safety assessment, analysis, and reporting across designated product(s) worldwide, including pre-marketing risk assessment, FIH planning, regulatory submission safety content, and development/execution of RMPs and/or REMS.
Key Duties and Responsibilities:
- Provide leadership/oversight of DASH/DST conduct, including pre-FIH benefit-risk assessment and strategy.
- Coordinate timely review of safety data to identify new safety signals.
- Develop and implement product risk management procedures/plans pre- and post-approval.
- Lead safety content for regulatory authority documents (SCS, CLO, Labelling) and development of REMS/RMP/equivalents.
- Collaborate on pharmacoepidemiology studies as needed.
- Review/assist with DSURs, PSURs/PBRERs, IND packages, and NDA/INDs.
- Provide safety input for labeling (IB, CCDS, USPI, SmPC, local labels).
- Provide responses to safety-related regulatory inquiries.
- Oversee medical review of adverse event reports and evaluate other non-AE/SAE safety information (toxicology, non-clinical, product quality).
- Oversee safety sections/content in key study and clinical reports (protocols, SAP, IB, ICF, IDMC charter, CSRs).
- Serve as subject matter expert for SOP/work instruction development; lead medical staff and develop direct reports.
Knowledge and Skills:
- Extensive knowledge of GCP, ICH, and global regulations.
- In-depth general medicine knowledge.
- Strong matrix leadership and communication.
- Ability to critically evaluate/interprete data and synthesize clear messaging.
- Extensive benefit-risk strategy/decision-making.
- Ability to multi-task.
Education and Experience:
- MD/DO (or equivalent ex-US medical degree).
- 12+ years pharmacovigilance experience and 7+ years supervisory/management experience (or equivalent).