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.
* 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.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.vrtx.com.
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.