GENERAL POSITION SUMMARY:
Reporting to the Vice President of Global Patient Safety, the Sr. Director of Clinical Epidemiology is responsible for leading the epidemiology group in supporting the overall safety and Benefit/Risk Management strategy for Vertex products. As a member of the senior leadership team in Global Patient Safety, he/she will shape and influence all aspects of the pharmacovigilance polices of the department. Using an integrated model, he/she will work closely with the safety physician groups, the QPPV, clinical development, regulatory affairs, medical affairs and across R&D.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
The Sr. Director, Clinical Epidemiology assists in developing and implementing strategy for safety processes and risk management activities, including refining signal detection processes and all RM processes and evaluations. As a member of the senior leadership team in Global Patient Safety, he/she serves as the expert to internal staff and external constituents, providing clinical epidemiologic benefit/risk management input. He/she is also be responsible for aiding the assessment of benefit-risk information, evaluation of safety signals and formulation of responses to regulatory inquiries. He/she ensures effective collaboration across functions, and is ultimately responsible for coordinating resources to ensure comprehensive risk management plans across the portfolio. He/she functions as a point person for pre- and post-marketing safety and epidemiologic issues.
- Shape the Risk-Benefit Management & Surveillance strategy at Vertex.
- Key leader in designing and conducting non-interventional observational studies, and registries.
- Participate in protocol development, specifically protocol design and statistical analysis plans, of clinical trials and other epidemiologic studies
- Significant input into Disease Area Safety Team meetings for investigational and marketed drugs
- Provide expertise for developing procedures to capture, manage and report clinical trial safety data.
- Serve as expert on product teams to provide guidance regarding safety and Risk-Benefit related issues.
- Interact with key opinion leaders in the field and identify appropriate investigators and study sites to conduct clinical trials and epidemiology studies.
- Significant input into periodic reports, risk management plans, and regulatory submissions such as NDAs, and MAAs.
- M.D. or PhD. in Epidemiology required
- Formal training in Epidemiology required
- 5+ years of pharmaceutical pharmacovigilance experience or equivalent in the field of clinical epidemiology.
- Solid knowledge of general medicine and clinical practice, evidenced by medical training and/or medical practice experience or designing/conducting clinical epidemiological trials.
- Strong knowledge of pharmacovigilance guidelines and regulations.
- Excellent verbal and written communication skills.
- Strong leadership skills, and experience working in a matrix environment
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, 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, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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