Job Description

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex's world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.

Key Duties and Responsibilities:

• Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.

• Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.

• Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.

• Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.

• Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.

• Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.

• Reviews and provides oversight of safety sections of clinical study reports.

• Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.

• Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.

• Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Extensive knowledge of GCP, ICH and Global regulations.

• In-depth and comprehensive knowledge of General Medicine.

• Strong leadership skills with the ability to communicate effectively in a matrix environment.

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.

• Extensive knowledge of Benefit-Risk strategies and decision-making.

• Ability to multi-task, adeptly handling multiple demands.

Education and Experience:

• MD, DO or equivalent ex-US medical degree

• 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience

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