Sr. Director GPS, Disease Area Safety Head- Renal/Pain
Reporting directly to the Head of Medical Safety and Benefit-Risk Management, the Disease-Area Safety Head (Physician) will lead all safety and benefit-risk related activities for products within their Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
The Disease-Area Safety Head will assist GPS Leadership in ensuring the consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Directly and/or via oversight of direct reports, the Disease-area Safety Head will lead 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. S/he will work closely with the program specific Clinical Teams, Medical Affairs, and Partners (as applicable) to proactively assess and address potential and identified safety issues for each product throughout the product life cycle.
- Provide leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre-FIH activities, benefit-risk assessment, and strategy for DSTs.
- Coordinate and oversee safety signals detection, in accordance with Vertex signal detection practices.
- Collaborate with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, as needed.
- Collaborate with NDA teams in support of submissions, specifically leading development of any SCS, CLO, Label and Risk Management Plan (RMP) or equivalent documents.
- Collaborate with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies.
- Review and/or assist in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, as well as NDA and IND, MAA Annual Safety Reports.
- Provide review and safety-specific input for labeling documents
- Collaborate with Regulatory Affairs to develop responses to safety related regulatory agency inquiries.
- Provide and oversee medical review of aggregate and individual post-marketing and clinical trial AE reports, in accordance with GPS review practices.
- Conduct medical evaluation of relevant safety information from Toxicology, Non-Clinical studies and Product Quality sources.
- Review and provide oversight for medical content for key study-related documents, e.g., Protocols, Analysis Plan, IB, ICF and IDMC Charter.
- Review and provide oversight in the analysis of safety data from on-going and completed clinical trials and Study Reports.
- Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
- Participate/serve as Subject Matter Expert in departmental activities, SOP development.
- Facilitate the growth and development of staff and direct reports.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
- Solid knowledge of General Medicine, including a doctorate in Medicine (M.D.)
- Extensive knowledge of GCP, ICH and Global regulations.
- At least 7 years Pharmacovigilance experience
- Strong leadership skills with the ability to communicate effectively in a matrix environment
- Experienced in the critical evaluation and interpretation of data, with ability to synthesize into coherent messaging
- Solid knowledge of Benefit-Risk strategies and decision-making
- Ability to multi-task, adeptly handling multiple demands.
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