Sr Manager, Clinical Epidemiology
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Employer: Vertex Pharmaceuticals
Located in: Boston, Massachusetts
Degree Required: PhD
GENERAL POSITION SUMMARY:
Senior Manager, Clinical Epidemiology supports safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of lifecycle. This includes supporting the execution of post-marketing commitment (PMC) research strategies, contributions to comprehensive epidemiologic feasibility assessments and development of epidemiologic study designs, study implementation, interpretation of findings and their communication to internal and external audiences.
Senior Manager, Clinical Epidemiology, is a subject matter expert in pharmacoepidemiologic methods, pharmacovigilance regulations, and specific therapeutic areas. Senior Manager collaborates cross-functionally within Global Patient Safety department and other line functions within the Global Medicines Development & Affairs organization.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
- Actively contributes to the company safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory studies design and implementation
- Expected to research the epidemiology of specific diseases via comprehensive and systematic epidemiologic literature reviews
- Clearly demonstrates a strong understanding of epidemiological principles and methods, and ability to independently apply these concepts in practice
- Supports the development of safety and regulatory epidemiologic strategy
- Contributes to all stages of the design and implementation of regulatory post-marketing studies: from feasibility assessments, development of study designs and protocols, and execution of studies, to communication and dissemination of their results to internal and external (e.g., Regulatory Agencies, scientific communities) stakeholders
- With autonomy, performs systematic and targeted literature reviews to support safety evaluation and / or post-marketing research strategies, with strong ability to disseminate information to diverse audiences
- Contributes to the development of epidemiology sections for Risk Management Plans (EU RMP, REMS, etc.) and other regulatory filings (NDA, PSUR, etc.) for products throughout lifecycle
- With autonomy, conducts quality control (QC) for all epidemiologic deliverables (study concept proposals, protocols, interim and final analyses reports, etc.)
- Supports PMC study execution teams
- Supports tracking and metrics of Clinical Epidemiology team deliverables
- Actively participates at Disease Safety Teams and Global Patient Safety staff meetings
PREFERRED EDUCATION AND EXPERIENCE:
- PhD in epidemiology required, pharmacoepidemiology training is preferred
- Experience in pharmaceutical/biotechnology industry, CRO, or academic setting preferred
- Solid understanding of study design methodology in general medicine and clinical practice, experience in designing/conducting epidemiology studies preferred
- Familiarity with pharmacovigilance guidelines and regulations is a plus
- Experience in statistical data analyses of clinical data
- Excellent verbal and written communication skills
- Good project management skills
- Ability to build strong collaborative relationships with stakeholders and business partners and to work effectively in a diverse matrix environment
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.
Posted on 06/25/2019
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