Director, Patient Reported Outcomes

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.

RESPONSIBILITIES AND ACCOUNTABILITIES

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    

REPORTING RELATIONSHIP

Reports To:

Head, Quantitative Clinical Sciences and Reporting

Direct Reports:

Associate Director, Patient Reported Outcomes

JOB SPECIFICATIONS

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.

Experience

• 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)

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.

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.

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