Patient Reported Outcomes Director
AstraZeneca / Apotekarjobb / Göteborg
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As a Patient Reported Outcomes Director at AstraZeneca, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. The Patient Reported Outcomes Director will set and lead TA-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 for driving high quality evidence claims by working with assigned TA(s) to:
* Guidance on which disease/therapy areas and early projects will need a PRO as endpoint
* Investigate to what extent PRO and Clinical Outcome Assessment 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 that new instruments and endpoints are developed and fit-for-purpose
* Provide PRO/COA/patient experience strategic advice on the planning, use and promotion of new or existing instruments
Accountabilities/Responsibilities:
* Deliver robust TA and project PRO regulatory recommendations globally
* Deliver expert input on PRO needs
* Briefing document evidence within the clinical plans and regulatory submissions
* Through internal and external communications channels increase PRO knowledge and effectiveness
* Resolve issues identified by CPTs, GPTs, GMTs, IPTs and Payer Teams
* Supports GPT and CPT in the design and interpretation of clinical studies
* Supervise vendors
* Prepares vendor proposal requests
* Budgeting responsibility for assigned projects
* Collaborations with academic researchers and clinical research organizations
* Discussions with regulatory authorities
* Validation research for consideration by eg, NICE, EMA, FDA
Minimum Requirements -Education and Experience:
* Bachelor's degree in clinical, biological, or social sciences
* Master's 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 bio-pharmaceutical 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
* Demonstrated track record 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
Skills and Capabilities:
* In-depth professional or expert knowledge of PRO/COA and its application to pharmaceutical development at an international level.
* Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages.
* Knowledge of international healthcare systems and their changing needs for PRO/COA information.
* Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims.
* Provide innovative scientific knowledge and leadership in patient centered evidence work teams.
* Leadership skills and problem-solving capability as demonstrated by ability to evaluate threats and opportunities for PRO strategy and modify as appropriate.
* Well-developed conceptual thinking with capability to access internal and external resources for advice.
* Proactive application of therapeutic area and disease treatment knowledge.
* Able to implement projects including interactions with key stakeholders with high degree of autonomy.
* Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
* Ability to define clear scope of project and provide strategic consultative support
* Ability to look for and champion more efficient and effective methods/processes
* Excellent written and verbal communication skills,
* Integrity and high ethical standards
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience and no later than December 16th - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you have additional questions please contact Katarina Halling at 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, gender or gender 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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-11-26ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-12-10
Ange följande referens när du ansöker: R-039746
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
sara.jagevall@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4481495
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