Associate Director, Patient Centred Outcomes (PCO)

at Kyowa Kirin International plc

Marlow, UK

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

You will contribute to the design and delivery of patient‑centred outcomes (PCO) strategies and implementation across Kyowa Kirin’s global product portfolio. You will ensure that patient experience data, including Patient‑Reported Outcomes (PROs), is rigorously developed, implemented, analysed, and communicated to support regulatory, clinical, commercial, and real‑world evidence objectives. This role provides an opportunity to develop foundational expertise in PCO/PRO methods while working closely with senior PCO team members to advance patient centred measurement within Kyowa Kirin

Key Responsibilities:

• Contribute to PRO endpoint strategies across KK’s development programs, ensuring alignment with scientific, regulatory, and commercial needs)
• Provide PRO expertise for pipeline activities, as well as for real‑world evidence and prospective observational studies within KK’s portfolio
• Manage qualitative and quantitative research activities, including concept elicitation, cognitive interviews, psychometric evaluation, and endpoint interpretation working with CROs
• Partner with clinical operations, biostatistics, regulatory affairs, medical affairs, and commercial teams to ensure optimal design, implementation, and analysis of patient‑centric endpoints in clinical trials
• Support strategic interactions with global regulatory agencies (FDA, EMA) by defining key PRO questions, preparing evidence packages, and ensuring responses reflect the latest scientific and regulatory expectations
• Build and maintain strong relationships with academic researchers, key opinion leaders, industry consortia, and patient advocacy groups
• Lead or contribute to high‑quality abstracts, posters, manuscripts, and conference presentations related to PRO/COA evidence
• Build internal capability on patient‑centred measurement by coaching and educating cross‑functional colleagues on PCO best practices

Position Requirements:

• Master’s degree (or higher) in psychology, epidemiology, public health, outcomes research, or related discipline
• Significant experience in PRO development, validation, and implementation in pharmaceutical and/or consulting environments
• Preferably some experience interacting with FDA/EMA on patient‑focused measurement strategies
• Demonstrated track record in designing and managing PRO studies across clinical trials and/or RWE settings
• Deep understanding of FDA PFDD Guidances and global PRO regulatory frameworks
• Knowledge of psychometric methods, PRO instrument development, scoring, and endpoint interpretation
• Strong scientific writing skills for regulatory, scientific, and publication outputs

Kyowa Kirin International is an equal opportunities employer.

No agencies please.