The Patient Centered Science (PCS) Director is responsible to develop therapeutic area clinical outcome assessments (COA)/patient reported outcomes (PRO) strategy.
Our vision inthePCSteam at AstraZeneca is tochange lives by amplifying the patient voice in health care decision making.We seek toidentify, 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 incorporatesthe patient journey intoresearchto 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.
The incumbent will be responsible to:
- 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;
SKILLS AND CAPABILITIES NEEDED
* Experience developing and executing COA/PRO strategy in a pharmaceutical company or consultancy
* Expertise in payer (e.g. NICE, G-BA) strategy and evidence generation
* 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 immunology or rheumatology
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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