Director, Epidemiology

CSL•Waltham, MA

3d•$250,000 - $280,000•Hybrid

About The Position

CSL Behring is seeking a Director, Epidemiology to join their team. This role will be responsible for defining and executing epidemiology research strategies to support R&D and Commercial objectives for designated products. The position involves planning, coordinating, and executing all aspects of epidemiology research programs, including protocol development, data analysis, and report generation. The Director will also contribute epidemiological data to regulatory submissions, lead benefit-risk assessments, and advance the use of Real-World Evidence (RWE) within the company. Additionally, the role will assist in the development and growth of the department and contribute to the implementation of best practices and SOPs.

Requirements

Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master’s degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry.
Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products.
Ability to proactively advise and lead product teams in this regard.
Sustained autonomous performance as epidemiology lead to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity.
Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting.
Demonstrated experience leading organizational process improvement or change management initiatives.
Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities.

Responsibilities

Proactively define epidemiology research strategies to contribute to R&D and Commercial objectives for designated products.
Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management.
Prepare results for internal decision making, regulatory agency submissions, publications and technical reports.
Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests).
Lead structured benefit-risk assessments, using qualitative and quantitative methods.
Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company.
Assist the head of department to facilitate ongoing development and growth of the department.
Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc.