Director, Epidemiology

CSL; Pennsylvania; Hybrid; USD 180,000 - 280,000; Full time

Job summary

CSL Behring seeks a Director of Epidemiology to lead research strategies for designated products, collaborating across R&D and Commercial teams in a hybrid model (King of Prussia, PA or Waltham, MA; three days onsite).

You will oversee study design, data collection and analyses, contribute to regulatory submissions and publications, and drive RWE initiatives while mentoring the department and promoting best practices.

Qualifications

• Doctoral degree in Epidemiology or related quantitative field with 10+ years in pharma.
• OR Master's in Epidemiology with 12+ years in pharma.
• Experience leading cross-functional teams in matrix structures and regulatory submissions.

Responsibilities

• Define epidemiology research strategies for products to support R&D and commercial goals.
• Plan, coordinate, and execute epidemiology studies from protocol to reporting.
• Contribute data to regulatory submissions and publications.
• Lead benefit-risk assessments using qualitative and quantitative methods.
• Advise on and advance use of RWE across the company.
• Support head of department and help grow the team.
• Help develop SOPs, templates, and best practices.

Skills

Epidemiology leadership

Cross-functional leadership

Regulatory submissions

Data analysis

RWE (Real-World Evidence)

Education

Doctoral degree in Epidemiology

Master's degree in Epidemiology

Tools

SAS

R

Job description

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. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role 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, 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.

Qualifications

• 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.