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 Epidemiologist? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three days onsite.
Responsibilities:
You will lead designated products proactively define epidemiology research strategies to contribute to R&D and Commercial Development 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.
• Contributes strategic and technical expertise in advancing the generation and utilization of RWE across the company.
Qualifications:
• Doctoral degree in epidemiology or related quantitative discipline preferably with post-doctoral experience in the pharmaceutical industry or Contract Research Organizations with a pharmaceutical company customer base. Or, Master’s degree in epidemiology or related quantitative discipline with at least 3 years of post-graduate experience in the pharmaceutical industry or Contract Research Organizations with a pharmaceutical company customer base.
• Demonstrated ability to independently carry out assigned duties, troubleshoot and identify technical and operational problems in the execution of duties, and to independently pursue solutions to ensure objectives are met efficiently and in a timely manner.
• Experience working successfully in cross-functional teams or in a matrix organizational structure.
• Experience in conducting high-quality comprehensive literature reviews and critically interpret epidemiologic data and publications.
• Knowledge of drug or vaccine development process.
• Proven ability to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple products with some supervision.
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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 of 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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.