Director, Epidemiology

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor.

About the role

This position is located in our King of Prussia, PA or Waltham, MA office. It is a hybrid role requiring three days onsite.

Responsibilities

• As the epidemiology lead for designated products, proactively define epidemiology research strategies to contribute to R&D and Commercial objectives.
• Plan, coordinate, and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, and 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 Real-World Evidence (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.

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 the 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 in a pharmaceutical industry setting.
• Demonstrated experience leading organizational process improvement or change management initiatives.
• Demonstrated knowledge and application of the broader business context (i.e., not only the role of Epidemiology) including R&D and Commercial development activities.

Pay

The expected base salary range for this position at hiring is $250,000–280,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies, and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Benefits

For more information on CSL benefits, visit How CSL Supports Your Well-being.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop, and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms—plasma fractionation, recombinant protein technology, and cell and gene therapy—to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.