Medical Evidence Generation Lead
We are AstraZeneca, one of the world’s most forward-thinking and connected BioPharmaceutical companies. With a strong purpose, an even stronger bond between each of our people and a science-led, patient-first attitude, we’re changing the future of medicine and the impact it can have on lives across the globe. Are you ready for a challenge?
Currently we are looking for Medical Evidence Generation Lead who
should lead the development and execution of comprehensive evidence plans for both pre-launch and launched products to address full breadth of internal and external stakeholder needs.
- Plan and deliver observational research and Real World Evidence (RWE) studies in Poland
- Lead the development and execution of comprehensive evidence plans for both pre-launch and launched products to address full breadth of internal and external stakeholder needs
- Identify and collaborate with key external experts to address identified evidence gaps, including academic-clinical investigators, health outcomes researchers and contract research organizations (CROs)
- Work collaboratively with Medical Advisors/Managers/TALs and Market Access colleagues to develop AstraZeneca-sponsored study protocols for local observational (both prospective and retrospective) studies, as well as review and advise on externally sponsored research proposals
- Managing Medical Evidence Generation team
- Identify and evaluate new health database and disease registry opportunities in Poland that could be used for real world studies in therapy areas of interest
- Liaise with global counterparts for all evidence generating activities and lead the review and approval process for local studies at AstraZeneca Poland
- Drive local and global study teams in order to deliver project-specific milestones and resulting scientific publications (e.g., conference presentations, peer-reviewed journal manuscripts) according to deadlines (e.g., HTA submission target)
- Develop and manage communication and knowledge translation plan for all evidence generating activities and ensure presentation of study results to appropriate internal and external stakeholders (e.g. Value teams, SMT, investigators)
- Lead site start-up activities such as ethics submission, informed consent review, development and finalization of research study agreements and follow-up and maintenance of all study related activities, if required, in accordance with AstraZeneca and international regulatory requirements.
- Develop and maintain study budget, timelines and resources and ensure appropriate updates are made to internal tracking systems
- Prepare, execute, track, collect, review and assess study documents and ensure their completeness according to external guidelines and AstraZeneca SOPs
- Complete study feasibilities for Global Non-Interventional Studies in collaboration with the local team and global counterparts
- Provide in-house epidemiology, statistics, and observational research methodology expertise to cross-functional partners, including Medical, Market Access and Regulatory teams
- MD or Biology/Pharmacy/science-related Master’s degree
- Experience in leading RWE projects in various areas
- Understanding of statistical principles and methodologies applicable to observational and other types of real-world studies (eg pragmatic trial design)
- Experience in data analytics and/or ability to work with different health databases an asset
- Excellent understanding of observational study methodology (design and interpretation) and externally sponsored research including clinical and pre-clinical research
- Demonstrated track record in observational research, demonstrating both strategic and tactical elements
- Demonstrated leadership ability in a team environment
- Experience in project management
- Excellent interpersonal, verbal and written communication skills
- Self-motivated and able to display autonomy and initiative – for instance; able to take action, move actions forward and make decisions without the need for continual supervision or consultation.
- Ability to interact with key external customers, including governments, payers, academic researchers and physicians
- Effective time management skills
- Good knowledge of MS Office (Word, Excel, PowerPoint)
Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.