Shire Epidemiology Lead in Lexington, Massachusetts
The Director, Epidemiology is a high-level, strategic and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and impactful epidemiology research for product support at a global level, from early development through life cycle management. The Director, Epidemiology provides essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact cross-functional project opportunities and risks, to ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs. The incumbent must be highly innovative, proactive and collaborative with mature team-working behaviors. As a member of the Outcomes Research and Epidemiology (ORE) department, an epidemiologist at Shire must have a broad view of the role of epidemiology and Pharmacoepidemiology in product support, contributing across target identification, through drug development, value demonstrations, market access, and post-approval effectiveness and safety. Epidemiologists interact with a wide range of internal and external customers to ensure appropriate communication of epidemiological issues and study results to stakeholders, including providing epidemiological support for interactions with regulatory authorities.
Develop product epidemiology strategy for drug development, pharmacovigilance, and commercial purposes across the product life cycle
Propose, design, initiate, conduct, manage, report, and present epidemiologic studies, following through on all review stakeholder management, and compliance processes
Critical appraisal and synthesis of relevant epidemiological literature, including to support exploration of new disease areas
Contribute appraisal and synthesis of relevant epidemiological literature, including the support exploration of new disease areas
Pharmacovigilance support, including risk management; PASS development and delivery; contributions to RMPs, PSURs, and regulatory responses; understanding inherent risks associated with a given product’s indication; providing population-level context for safety; understanding and responding to potential safety issues
Maintain awareness of regulatory requirements, payer trends, external pharmacoepidemiologic initiatives, and advances in pharmacoepidemiologic methodology; support strategic development of the Epidemiology function within Shire; remain current on the capabilities of key external research partners.
Education and Experience Requirements
PH.D. in epidemiology or a related field, or a Master’s degree in epidemiology, and a least 10 years preferred experience in life science related field is preferred
Sustained productivity in epidemiological research, as manifest by successful design, execution, and publications of epidemiological research, including through extensive collaboration with external investigators, as well as recognition by the external scientific communities as an expert in areas relevant to drug development, pharmacovigilance, and commercialization, from early development through life cycle management
Preferred: experience with epidemiology of orphan drugs, comparative effectiveness research, personalized medicine, direct interaction with regulatory authorities, patient risk management program evaluation, business development due diligence
Other Job Requirements
- Domestic and international travel required. Must have a global mindset. Fluency in main European languages would be desirable.
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.