Director / Senior Director, Clinical Outcomes Assessment (COA)

Location

Ideally United Kingdom; candidates based elsewhere in Europe will also be considered.

About Shionogi

At Shionogi, we are committed to incorporating the voice of the patient into our clinical development programmes. We believe that understanding and measuring the patient experience is fundamental to delivering meaningful outcomes for patients, healthcare systems and society.

We are seeking a Director / Senior Director, Clinical Outcomes Assessment (COA) Strategy, Development & Implementation to lead the development and implementation of patient-centred COA strategies across our global development portfolio.

This role is responsible for ensuring patient-centred, regulatory-acceptable and value-driven endpoints are incorporated into development programmes. The successful candidate will provide strategic leadership to cross-functional teams and ensure COA measures are fit-for-purpose to inform patient-physician treatment strategies, health technology assessments and payer decision-making.

The position sits within Global Scientific Operations, alongside Value & Access, Epidemiology & Real-World Evidence, and Medical Affairs.

Key Responsibilities

• Engage with assets across the pipeline to identify patient-relevant concepts and guide asset teams on COA measures that support clinical trial endpoints.
• Determine whether COA measures are fit-for-purpose for label inclusion and guide cross-functional teams in assessing label worthiness based on FDA Patient-Focused Drug Development (PFDD) guidance.
• Conduct landscape assessments to understand patient concepts of interest and meaningful aspects of health within specific disease areas.
• Conduct concept elicitation activities to identify and confirm patient-relevant concepts and meaningful health outcomes.
• Determine whether existing COA measures should be utilised, modified or whether de novo measures should be developed to support claims, market differentiation and access-related decision-making.
• Conduct cognitive interviewing where development of new measures is required.
• Collect patient experience data, including embedded clinical trial interviews.
• Partner with regulatory colleagues to develop briefing materials and obtain feedback regarding measure development and implementation strategies.
• Develop and oversee psychometric analysis plans to generate evidence that COA measures are fit-for-purpose within their intended context of use.
• Work closely with Clinical Operations and external eCOA vendors to ensure high-quality implementation, minimise missing data and maintain robust reporting standards.
• Drive innovative approaches in COA measurement science and support Shionogi's ambition to be a recognised leader in the field.
• Represent Shionogi at relevant scientific conferences and congresses.
• Contribute to Shionogi's COA Centre of Expertise by sharing knowledge, building capability and monitoring emerging market trends.
• Collaborate with policy and market access colleagues to advance the use of patient experience data in healthcare decision-making and clinical practice.