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Director, Patient Reported Outcomes

CSL Behring
King of Prussia, Pennsylvania
Start date
Jan 18, 2023

Job Details

Job Description

The Director of Patient Reported Outcomes is responsible for the strategic planning and implementation of PROs for all pharmaceutical compounds in the R&D pipeline. You will also collaborate with the internal clinical and commercial development teams to develop appropriate strategies for product approval, labeling and reimbursement depending on the respective needs of the teams involved. The goal of this collaboration is to ensure that the PRO strategy provides competitive value and that it aligns with the overall market access strategy for the product.

At CSLB the position is located within Quantitative Clinical Science and Reporting (QCSR) department. The role works closely with other groups across the company including Clinical Research and Development and Commercial Development. The role includes participation in global teams, interactions with regulatory agencies in multiple countries, and presentation and publication of research outcomes.


1. Lead development of a patient reported outcome strategy for the CSL Behring compounds in development as well as marketed products when needed

2. Select and/or develop appropriate PROs for various CSL Behring clinical development programs

3. Conduct market specific research to determine the influence of PROs in different countries and the criteria that must be met for the PROs to influence regulatory approval, labeling decisions and reimbursement

4. Conduct research on the existing validation of PROs and identification of the need for additional validation depending on the purpose for which it is being used

5. Assist with including PROs in study protocols and statistical analysis plans and support the analysis of the PRO data when studies are completed

6. Interpret PRO clinical trial results and review relevant sections of documentation and communication for regulatory agencies and HTA agencies to provide the necessary evidence in support of submission activities

7. Responsible for PRO publication plans and leads the development of abstracts and manuscripts on PRO results from clinical and other studies

8. Collaborates with external patient advocacy organizations, regulatory agencies and related organizations focusing on PRO development to ensure successful inclusion of PRO data in regulatory labels and approvals when needed

9. Represents CSL Behring in key external meetings/working groups related to PROs    


Reports To:

Head, Quantitative Clinical Sciences and Reporting

Direct Reports:

Associate Director, Patient Reported Outcomes


A minimum of a Master’s degree in the field of Psychology, Psychometrics, Sociology, Health Economics, Biostatistics, Epidemiology, Public Health or Health Services Research is required. A PhD, PharmD or MD is strongly preferred.


  • Demonstrated experience in strategic planning and use of patient reported outcomes in clinical studies
  • Experience managing contract research organizations
  • Track record of innovation desired
  • Some supervisory experience
  • Competencies
  • Expertise and experience in the strategy, conceptual basis, methodology and application of PRO and other health outcome measures in the context of clinical studies is required.
  • Superior understanding of and expertise in selection of patient reported outcomes and validation of PRO measures
  • Demonstrated ability to strategically plan for the optimal, fit for purpose application of PROs in product development
  • Established superior negotiation and influencing skills with cross-functional teams, external collaborators and regulatory agencies related to scientific and operational decisions.
  • Demonstrated track record of peer reviewed publications
  • In depth knowledge of drug or vaccine development process and Regulatory pathways including relevant regulations. Demonstrated knowledge (and application of that knowledge) of the big picture of the business including Clinical and Commercial development activities.
  • Sustained demonstration of independently conducting high quality complex research projects.
  • Strong working knowledge and application of the 2009 FDA "Guidance for Industry Patient-Reported Outcome Measures: Use in - Medical Product Development to Support Labeling Claims" and other relevant PRO and Patient Focused Drug Development guidances and best practices is required.
  • Strong interpersonal and organizational skills
  • Strong verbal, written and presentation skills and excellent written and spoken English.
  • Established leader of internal and external strategic initiatives; Represents CSL Behring in external workgroups or initiatives (e.g., Industry-wide, Academic, Professional Societies)

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!


As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 

CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 

CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
1020 First Avenue
King of Prussia

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