GSK is seeking a Director, PRO/COA with experience in Oncology.
- In this role, you will ensure that the patient’s voice is included in product development and will have the opportunity to develop novel innovative endpoints that inform technical success in drug development, facilitate market access.
- You will also be responsible for development of PRO/COA endpoint strategies, and development and validation of PROs to support registration, reimbursement and differentiation of GSK assets in development.
- The Patient-Center Outcomes (PCO) team provides consultancy and scientific expertise to support internal stakeholders in Clinical, Regulatory, Value Evidence and Outcomes and Patient Engagement.
- The PCO team is also involved in external initiatives to support GSK’s expertise in patient engagement, measurement and novel endpoint development to inform treatment benefit including CPATH, NIH, ISOQOL and PCORI).
- The GSK PCO team is a global multidisciplinary group including Health Outcomes Researchers, Epidemiologists, Clinical Scientists and statisticians.
- In this role you will lead the development of global measurement strategies such as Patient-Reported Outcomes (PROs) and Clinician Reported Outcomes (ClinROs) for multiple molecules within an actively growing Oncology protfolio.
- As a Director of Oncology PRO/COAs, you should be recognized in the field of outcomes research with experience in the pharmaceutical industry or regulatory environment, and may include experience in contract research organizations or academic settings.
- Your role will be exciting and varied as you will be involved in a range of responsibilities.
- These include establishing and leading PCOR disease area strategies that support establishment of humanistic impact of a condition and its treatment on patients and caregivers; reviewing, modifying or developing conceptual models and developing hierarchical endpoint models.
- You will be responsible for assessing whether instruments are Fit-for-Purpose with attention to content validity and psychometric properties specific to context of use.
- You will make strategic recommendations to address any gaps in evidence support a PRO/COA for regulatory submissions, and develop and support research to develop qualitative and quantitative evidence of a PRO/COA as fit for purpose and leading to PRO Dossiers.
- You will define endpoint strategies, author PRO/COA sections of protocols and analysis plans, and support interactions with regulators with respect to PRO/COA endpoints.
- n this role, you will be responsible for managing vendors including work development, contract initiation, project milestones, timelines, deliverables, and budgets.
- You will need to have excellent communication and project management skills to develop professional relationships that will enable you to act as PCOR functional lead in cross-functional teams to establish needs and develop PCOR strategies.
Your strong leadership skills will enable you to successfully mentor scientists in the Patient Centered Outcomes team, as well as Value Evidence and Outcomes.
- You may be called upon to participate on various leadership teams as required.
- You will also have opportunity to contribute to external efforts such as International Society of Quality of Life Research (ISOQOL), International Society of Pharmacoeconomics & Outcomes Research (ISPOR), CPATH, FDA initiatives, National Institute of Health (NIH) initiatives etc.
• Developing global PRO/COA endpoint strategic plans in collaboration with early and late stage clinical development teams, health outcomes and integrated evidence teams to assure alignment with product franchise goals
• Implementing PRO)/ COA strategies for assets in development, assuring alignment with clinical, health outcomes and commercial strategies and overall clinical development plan
• Coordinating and leading the development, validation, analysis, interpretation and utilization of PRO/COAs in the context of clinical trials and/or observational studies
• Ensuring PROs are implemented appropriately in clinical trials, which include writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials
• Collaborating with clinical and statistical teams to ensure that COAs are appropriately analyzed and described in statistical analysis plans, study reports and publications
• Preparing relevant sections of documentation and communication and questions for regulatory agency meetings, supporting and/or participating in meetings at regulatory agencies, and providing robust evidence in support of submission activities
• Preparing abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy
• Collaborating externally to ensure that GSK has expertise in newly evolving COA methodologies and is recognized as a leader in COA development and implementation
• With PRO team, developing and providing training on COA-related topics to other departments, as needed
- Hold a Master’s degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology or a closely related discipline
- Have experience in pharmaceuticals, particularly in oncology drug development, so as to understand drug development process
- Have experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies including understanding of the FDA Patient Reported Outcomes Guidance
- Have experience with managing PRO development and validation projects
- Have demonstrated your communication skills, with stakeholder engagement with Clinical, Health outcomes and Regulatory