Director / Senior Director, Clinical Outcomes Assessment (COA) Strategy, Development & Implementation
Description
Shape the Future of Healthcare with Shionogi
At Shionogi, we are dedicated to improving global health and well-being. As a leading pharmaceutical company, we are committed to innovation, excellence, and making a positive impact on healthcare worldwide. Join us in our mission to shape the future of healthcare and make a difference in the lives of millions.
Why Choose Shionogi?
Shionogi offers a dynamic, collaborative work environment where you can grow your career and contribute to ground breaking healthcare advancements. We value diversity, inclusion, and the unique perspectives that each team member brings. At Shionogi, you will have the opportunity to work with talented professionals, engage in meaningful projects, and be part of a company that is at the forefront of medical innovation.
About the Role
In this newly created role, as the Director / Senior Director of COA Strategy, Development & Implementation, you will be responsible to ensure assets across the pipeline, including those focused on rare diseases, have included the right COA instruments, that are fit for purpose and appropriate for label inclusion, to support given patient-centred endpoints.
Some of your responsibilities will include:
- Identifying patient-relevant concepts and guiding asset teams on COA instruments
- Conduct landscape assessments to better understand relevant patient concepts for a given disease area.
- Conducting landscape assessments and concept elicitation
- Developing and overseeing psychometric analysis plans
- Engaging with colleagues across functions to ensure COA instruments are fit for purpose
What We Are Looking For
We are seeking a highly experienced and strategic individual with:
- Expertise in COA-related strategies in the pharmaceutical industry, with experience of developing de novo COAs
- Deep subject matter expertise in FDA’s PRO and PFDD guidance documents
- Experience of COA strategies ideally for rare diseases
- Strong communication and project management skills
- Ability to work with patient advocacy organisations and
- Demonstrated ability to work and influence cross-functionally
- Willingness to travel 30% of the time
- Masters or PhD in health sciences, psychology, statistics, or related field
Join Us: If you are passionate about improving patient outcomes and driving innovation in clinical outcomes assessment, please apply. Together, we can make a difference in the lives of patients with rare diseases.