Proclinical are partnered with a truly exciting Mid-Sized Global Pharma that specialise within the Rare Disease space. The business have become one of the most recognized pioneers within multiple Rare Diseases and are now in a very strong position with numerous studies already approved alongside a highly innovative pipeline that is continuously growing.
This opportunity is part of a continuous growth plan as the company are heavily investing into their Epidemiology function at their Global Headquarters in Cambridge, MA. This department is a critical part of the companies overall growth plan as they understand the importance of having a first-in-class Epidemiology department as they continue to grow.
Primary Responsibilities:
The Director, Epidemiology is a senior strategic and scientific leadership role that provides global direction and expertise for epidemiology support for programs within their therapeutic area, requiring minimal supervision. You will partner with cross-functional stakeholders to ensure appropriate epidemiological perspectives are provided in support of strategic needs and integrated into corporate plans.
Alongside this, you will be accountable for developing and implementing cutting-edge, effective and impactful epidemiology deliverables, ensuring all deliverables are performed efficiently, commensurate with budget, quality, accuracy, timeliness, and in accordance with current advancements in epidemiology / pharmacoepidemiology methodology.
Specific responsibilities will include:
- Accountable for developing plan for Epidemiology deliverables (e.g. systematic literature reviews, database studies, analysis within primary observational studies/disease registries, PASS/PMCs) for assigned indications
- Lead the execution of deliverables in accordance with the plan, either personally or through oversight of other Epidemiologists/vendors/contractors.
- Accountable for providing epidemiology support to Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial activities across the product life cycle. Active participation on cross-functional therapeutic area teams. Lead sub-team meetings as appropriate.
- Accountable for ensuring epidemiology perspective into company materials e.g. study protocols, case report forms (CRFs), and regulatory documents within assigned indications within the therapeutic areas.
- Interact with authors and in-house reviewers on scientific manuscripts, clinical conference abstracts, presentations, and posters based on observational study data.
- Represent Epidemiology and Real World Science department during interactions with key external stakeholders including Scientific Advisory Boards and regulatory authorities.
- Critical appraisal and synthesis of relevant epidemiological literature.
- Maintain awareness of epidemiology with respect to regulatory requirements, payer trends, and advancement of pharmacoepidemiology methods.
- Represent Epidemiology and Real World Science department and participate in corporate cross-functional business / process improvement initiatives.
Skills & Requirements:
- Degree in Epidemiology or a related field.
- Minimum of 5 years experience in Epidemiology within the Pharma/Biotech/CRO industry
- Excellent verbal and written communication skills
If you are having difficulty in applying or if you have any questions, please contact George Breen at g.breen@proclinical.com
Apply Now:
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