Executive Medical Director, Patient Safety (Hybrid)

Executive Medical Director, Patient Safety / Head Medical Safety And Risk Management

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 :

Education And Experience :

Pay Range : $312,000 - $468,000

Disclosure Statement : The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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 pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation : Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status : In this Hybrid-Eligible role, you can choose to be designated as : 1. Hybrid : work remotely up to two days per week; or select 2. On-Site : work five days per week on-site with ad hoc flexibility.

Company Information : Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.