At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. The Patient Reported Outcomes Director will set and lead TA-level (and underlying project-level) PRO strategies and direct delivery of such plans to ensure high quality evidence supporting products’ regulatory approval, reimbursement and commercialization.
Main Duties and Responsibilities
The incumbent will be responsible for driving high quality evidence claims by working with assigned TA(s) (and their underlying projects) across the development cycle to:
• Determine and deliver guidance on which disease/therapy areas and early projects will need a PRO as a clinical endpoint;
• Investigate to what extent PRO and Clinical Outcome Assessment (COA) endpoints are developed, fit-for-purpose and approved by Regulatory Authorities and also how well they will meet AZ project needs, to provide the most appropriate PRO strategic recommendation;
• Ensure, when relevant, that new instruments are developed and fit-for-purpose;
• Provide PRO and COA strategic advice on the planning, use and promotion of new or existing instruments for AZ products to ensure consistency, coordination and quality within and across projects.
The incumbent will interact with regulatory authorities and key opinion leaders, as well as with relevant AZ cross-functional teams (eg, GPTs, CPTs, GMTs, Payer Teams), to provide PRO related leadership to assigned projects, and will be accountable for TA PRO standards, the input to TPPs/TPC and clinical plans. The role holder will ensure that fit-for-purpose PRO recommendations are based on scientific patient input and insight and documentation have been completed and assembled for PRO dossier discussions and submissions.
The role holder will participate as an expert with cross-functional teams (eg, IPT, GPT, Payer Team, where appropriate), with the IMED and GMD global project teams to ensure PROs are planned and discussed with regulatory authorities and with appropriate timing and context to facilitate decision making. The role will lead the TA PRO regulatory discussions, plans, submissions and work with colleagues in relevant markets to support payer evidence needs (such as utility and patient preference measurements). The role holder will also work with GMA to leverage the PRO information to make it available to patients, prescribers and regions.
- Bachelor’s degree in clinical, biological, or social sciences
- Masters degree in relevant field (outcomes research, health services research, epidemiology, health policy or related fields)
- Doctoral degree in relevant field preferred
- Minimum of 5 years experience in the biopharmaceutical industry
- Relevant experience of PRO scientific work
- Excellent knowledge in clinical development and research study designs and interpretation.
- Good understanding of qualitative and quantitative analyses applicable to patient insights, feeling and functioning
- Demonstrated track record in delivering a new capability or driving a change effort.
- Effectiveness in a scientific advisory role involving both strategic and tactical elements
- Knowledge of AZ’s prioritized disease and therapeutic areas
- Experience in partnering and collaborating with external vendors/agencies
- Open to periods of extensive travel
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law