Patient Safety Medical Director

About the Role

The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the assigned Disease-area and/or Franchise. This includes oversight from first in-human clinical trials through commercialization. The role ensures consistency and compliance in safety assessment, analysis, and reporting for designated products across Vertex’s global markets. Responsibilities span pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content in regulatory submissions, and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). The role involves close collaboration with Clinical Teams, Medical Affairs, and Partners to proactively address safety issues throughout the product lifecycle.

Responsibilities

• Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre-FIH activities, benefit-risk assessment, and strategy for Development Safety Teams (DSTs).
• Coordinates and oversees safety signals detection in accordance with Vertex signal detection practices.
• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product.
• Leads development of safety content for regulatory submissions, including Safety Concern Sections (SCS), Clinical Overview (CLO), Labeling, and Risk Management Plans (RMPs).
• Collaborates with GPS Epidemiology on the development, implementation, and reporting of pharmacoepidemiology studies.
• Reviews and assists in preparation of Developmental and Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, NDA and IND, and MAA Annual Safety Reports.
• Provides safety-specific input for labeling documents.
• Collaborates with Regulatory Affairs to develop responses to safety-related regulatory agency inquiries.
• Oversees medical review of aggregate and individual post-marketing and clinical trial adverse event (AE) reports.
• Conducts medical evaluation of safety information from Toxicology, Non-Clinical studies, and Product Quality sources.
• Reviews and provides oversight for medical content in key study-related documents (e.g., Protocols, Analysis Plans, Investigator’s Brochures, Informed Consent Forms, IDMC Charters).
• Reviews and provides oversight in the analysis of safety data from ongoing and completed clinical trials and Study Reports.
• Contributes to Partner/Affiliate agreements and interactions as needed.
• Serves as Subject Matter Expert in departmental activities and Standard Operating Procedure (SOP) development.
• Facilitates the growth and development of staff and direct reports.

Requirements

• Doctorate in Medicine (M.D.) required.
• Typically requires 7 years of work experience, including some experience in Pharmacovigilance, and 5 years of supervisory/management experience, or an equivalent combination of education and experience.

Skills

• Broad and comprehensive knowledge of General Medicine.
• Extensive knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulations.
• Strong leadership skills with the ability to communicate effectively in a matrix environment.
• Experience in critical evaluation and interpretation of data, with the ability to synthesize into coherent messaging.
• Comprehensive knowledge of Benefit-Risk strategies and decision-making.
• Ability to multi-task and adeptly handle multiple demands.

Pay

The pay range for this role is $276,000 - $414,000. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary will be based on skills, competencies, experience, and other job-related factors permitted by law.

Benefits

• Inclusive market-leading medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan and additional financial benefits.

Schedule

This is a Hybrid-Eligible role, allowing you to work remotely up to two days per week or choose to work on-site five days per week with ad hoc flexibility. The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.