Executive Medical Director, Patient Safety (Hybrid)

Role Summary

Executive Medical Director, Patient Safety (Hybrid) at Vertex. Oversees safety and benefit-risk activities within the Global Patient Safety department, leading DASH/DST teams and ensuring consistent risk management across designated products globally. Collaborates with Cross-functional leaders to plan and execute pre- and post-marketing safety strategies, regulatory submissions, and risk management planning.

Responsibilities

• Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct across all products, including pre-FIH activities and risk assessment.
• Coordinates and oversees timely review of safety data to identify new safety signals according to signal detection practices.
• Collaborates with Clinical Leaders to develop and implement risk management procedures/plans pre- and post-approval as needed.
• Leads safety content for regulatory submissions (SCS, CLO, Labelling) and development of REMS/RMP documents.
• Works with GPS Epidemiology on pharmacoepidemiology studies as needed.
• Reviews DSURs/PSURs/PBRERs, IND packages, NDA and INDs; provides safety input for labeling documents (IB, CCDS, USPI, SmPC).
• Collaborates with Regulatory Affairs to respond to safety inquiries.
• Oversees medical review of post-marketing and clinical trial adverse event reports.
• Oversees medical evaluation of other safety information (toxicology, non-clinical, product quality).
• Reviews safety content for study documents (Protocols, SAP, IB, ICF, IDMC Charter) and Clinical Study Reports.
• Contributes to Partner/Affiliate agreements and interacts as needed.
• Serves as Subject Matter Expert for SOP/Work Instructions development.
• Leads medical staff and liaises with Operations on adverse event collection and processing.
• Guides direct reports on DASH/DST Chair responsibilities and medical input for pre- and post-marketing activities.
• Facilitates growth and development of staff and direct reports.

Qualifications

• MD, DO or equivalent ex-US medical degree
• 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience

Skills

• Extensive knowledge of GCP, ICH and global regulations
• Strong leadership and matrix communication skills
• Ability to critically evaluate and synthesize data into clear messaging
• Extensive knowledge of Benefit-Risk strategies and decision-making
• Ability to multi-task and manage multiple demands