Patient Centered Science Director, Cardiovascular-Renal-Metabolic
AstraZeneca

Job Info

Patient Centered Science Director, Cardiovascular-Renal-Metabolic (CVRM) area

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.

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 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

Why AstraZeneca?

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.

The PCS group at AstraZeneca exist of nearly 20 persons, with a passion for including patient perspective in drug development, we are a group with diversity that enjoy leading and develop the field of patient centered science, do you want to work in a vibrant group this is your opportunity!