Reporting to the Senior Director of Clinical Epidemiology, the Associate Director, Clinical Epidemiology is responsible for the execution of epidemiology deliverables across multiple therapeutic areas and throughout all phases of product lifecycle. He/she has subject matter expertise in pharmacoepidemiologic methods and specific therapeutic areas.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
He/she participates in cross functional teams regarding risk management, signal detection, and benefit/risk profiling. He/she is expected to research the epidemiology of specific diseases, and to apply expertise in the design and analysis of observational studies, contribute to epidemiology requirements for regulatory documents, and participate in pharmacoepidemiologic analyses.
* Provides epidemiologic strategy to product teams
* Provides epidemiologic input into strategic documents, including regulatory filings (NDA, PSUR, etc)
* Manages and produces Risk Management Plans (DRMP, RMP, REMS, etc) for products throughout lifecycle
* Executes Risk Management Plans (RMP, REMS, etc)
* Performs systematic literature reviews
* Performs signal detection analyses of safety reporting system databases (AERS, Vigibase) using data mining software
* Actively participates including making presentations at meetings including product safety team and Global Patient Safety staff meetings
* Designs and produces protocols for observational studies using automated data or primary data collection
* May supervise interns and/or contractors
PREFERRED EDUCATION AND EXPERIENCE:
* MS with 10+ years of related work experience required
* PhD in epidemiology or MD with Master’s degree in epidemiology or public health preferred
* 5+ years experience in pharmaceutical/biotechnology industry, CRO, or drug development company
* Strong knowledge in pharmacovigilance guidelines and regulations; knowledge of international PV regulations is a plus
* Experience with data mining software is a plus
* Solid knowledge of study methodology in general medicine and clinical practice, evidenced by experience in designing/conducting epidemiology studies
* Excellent verbal and written communication skills
* Good project management and presentation skills
* Ability to build strong collaborative relationships with stakeholders and business partners
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.