AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.
A place to be at the forefront, we use our unique position as medical leaders across our enterprise and the healthcare ecosystem to shape the future of Healthcare. There's so much opportunity here as we continue to grow - no better place to improve patients' lives and develop with AstraZeneca.
What you'll do
The Patient Centered Science (PCS) Director is responsible to develop therapeutic area clinical outcome assessments (COA)/patient reported outcomes (PRO) strategy.
Our vision in the PCS team at AstraZeneca is to change lives by amplifying the patient voice in health care decision making. We seek to identify, understand, and measure meaningful aspects of the patient experience including symptoms, health status and health-related quality of life . Using qualitative and quantitative research as a foundation, PCS incorporates the patient journey into research to serve the needs of our patients.
The Patient Centered Science Director will set and lead therapeutic area-level (and underlying project-level) PRO and Patient experience strategies and direct delivery of such plans to ensure high quality evidence supporting products' regulatory approval, reimbursement and commercialization.
You will be responsible for:
Establish, maintain, and modify TA level strategies to develop and measure COA/PRO data that is fit-for-purpose across the product lifecycle
Engage with health agencies and regulatory authorities in the context of COA/PRO evidence generation, endpoint development, and research results
Engage and lead TA level strategy with study teams in AZ including COA/PRO protocol writing, statistical analysis plans, psychometric statistical analysis, and scientific dissemination
Ensure, when relevant, that new instruments and endpoints are developed and fit-for-purpose and that new innovative methods are developed to meet all key stakeholder needs;
Essential for the role
• Experience developing and executing COA/PRO strategy in a pharmaceutical company or consultancy
• Expertise in regulatory (e.g. FDA, EMA) strategy and evidence generation
• Experience in patient-centered endpoints use in post-marketing studies and lifecycle management
• Expertise in psychometrics
• Expertise in the cardio renal area is a merit