Senior Medical Director, Patient Safety Leader

5 days ago


Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Job Summary

We are seeking a highly skilled Senior Medical Director, Patient Safety to lead our safety and benefit-risk related activities for products within the Disease Area and/or Franchise. This role will assist Global Patient Safety (GPS) Leadership in ensuring consistency and compliance in safety assessment, analysis, and reporting for all designated products worldwide.

Key Responsibilities
  • Provide leadership and oversight of Safety Teams for products within assigned therapeutic areas, 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 ongoing and completed clinical trials and Study Reports.
  • Provide contributory to Partner/Affiliate agreements and interactions, as needed.
  • Serve as Subject Matter Expert in departmental activities, SOP development.
  • Facilitate the growth and development of staff and direct reports.
Requirements
  • Broad and comprehensive knowledge of General Medicine.
  • Extensive knowledge of GCP, ICH, and Global regulations.
  • 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 coherent messaging.
  • Comprehensive knowledge of Benefit-Risk strategies and decision-making.
  • Ability to multi-task, adeptly handling multiple demands.
Education and Experience

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

We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

  • Hybrid and work remotely up to two days per week; or select
  • On-Site and work 5 days per week with ad hoc flexibility.

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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com



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