Director/Senior Director, Clinical Outcomes Assessment (COA) Strategy, Development & Implementation

Responsibilities

• 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.
• Conduct concept elicitation to identify and/or confirm patient-relevant concepts of interest and meaningful aspects of health specific to 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.
• Conduct cognitive interviews if developing de novo measures. Collect patient experience data including conduct embedded clinical trial interviews.
• Engage with regulatory colleagues to complete briefing books to gain FDA guidance on measure development and/or inclusion in clinical trials to ensure measures supporting endpoints will be acceptable for label inclusion.
• 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.
• Work with clinical operations to ensure data missingness is reduced; that eCOA suppliers have the necessary skill set to effectively implement the COAs that have been included in the protocol and appropriate data reporting is undertaken on a regular basis to ensure quality data is being collected.
• Enable out-of-the-box thinking to enable Shionogi to be an innovator in the area of COA measurement science.
• Participate in relevant conferences and congresses to help establish Shionogi as a COA measurement science innovator.
• Contribute to Shionogi’s COA Center of Expertise (COE) to help deepen and strengthen cross-functional colleagues’ knowledge of COA measurement sciences and developing market trends.
• Work with colleagues in policy to help inform strategies to further advance the use of patient experience data to help inform access-related decision-making and patient care in clinical practice.

Qualifications

• 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.

Competencies

• 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.