Director/Senior Director, Clinical Outcomes Assessment (COA) Strategy, Development & Implementation
$215,000–$295,000 year
On-siteFlorham Park, New Jersey, United States
Job Summary
Engage with assets across the pipeline to identify patient-relevant concepts and guide decision-making on COA measures that support clinical trial endpoints. Determine if COA measures are fit-for-purpose for label inclusion by assessing them against FDA regulatory guidance and develop de novo measures to inform claims and access decisions. Conduct landscape assessments and concept elicitation to confirm meaningful aspects of health, while performing cognitive interviews and collecting patient experience data through embedded clinical trial interviews. Collaborate with regulatory colleagues to complete briefing books for FDA guidance and work with clinical operations to reduce data missingness and ensure high-quality data collection. Develop psychometric analysis plans to generate evidence on measure fit for purpose and contribute to the COA Center of Expertise to strengthen cross-functional knowledge. Participate in conferences to establish Shionogi as a COA measurement science innovator and work with policy colleagues to advance patient experience data for access-related decision-making.
Required Qualifications
- Masters or PhD in health sciences, psychology, statistics or another related field
- 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 communication skills including written and verbal
- Ability to engage with colleagues in commercial, medical, clinical, development, regulatory, market access, and other relevant functions to gain alignment on COA-related strategic and tactical plans
- Ability to think out-of-the-box to identify and implement strategic frameworks to utilize multimodal measurement strategies to assess treatment effect including biomarkers and wearable devices
- Willingness to be a team player and engage with colleagues in a collaborative manner
- Strong project management skills including achieving project milestones and maintaining timelines
- Strong work ethic and a commitment to operational excellence
- Ability and willingness to travel approximately 30% of the year both domestically and internationally
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ
- Office presence required at least 50% of the time per month
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