Engage with assets across the pipeline to identify patient-relevant concepts, guide asset team’s decision on COA measures that support clinical trials endpoints.
Determine if COA measures are fit-for-purpose for label inclusion; guide the cross-functional team to assess COAs’ label worthiness based on FDA regulatory guidance (2018-2023 PFDD guidance documents).
Conduct landscape assessments to better understand relevant patient concepts of interest and meaningful aspects of health for a given disease area.
Determine whether to use publicly available COA measures as is, modify or develop de novo measures based on COA strategies that will inform necessary claims, support market differentiation, and access-related decision-making to improve patient and health system outcomes.
Collect patient experience data including conduct embedded clinical trial interviews.
Develop and oversee psychometric analysis plans to generate evidence that COA measures used in clinical trials are fit for purpose in the specific context of use.

Masters or PhD in health sciences, psychology, statistics or another related field.
Requires a minimum of 7 years (Director) or 10+ years (Senior Director) of experience within pharmaceutical industry with responsibility for developing and implementing COA-related strategies and tactics.
Deep subject matter expertise in COA measurement sciences.
Strong working knowledge of FDA’s 2018-2023 PFDD Guidance Documents including market trends.
Understanding of quality reporting to ensure data collection is consistent within and across measures; that outliers are appropriately identified and sites are trained to improve quality data collection.
Strong project management skills including achieving project milestones and maintaining timelines.
Ability and willingness to travel approximately 30% of the year both domestically and internationally.

Director/Senior Director, Clinical Outcomes Assessment Strategy, Development & Implementation

Key skills