Director- Global Outcomes and Real World Evidence
- Experience Level
I am working with a leading biopharmaceutical company that is focused on the discovery, development, and commercialization of novel medicines to meet medical needs in oncology and inflammation and autoimmunity.
Job Summary (Primary function)
Execution of real-world evidence generation activities.
Support the development of epidemiology / pharmaco-epidemiology research that lead to scientific publications and reimbursement dossier development.
Responsible for driving cross-functional discussions
Developing and executing the Outcomes Research strategy and ensuring coordination with Global Value, Access, & Pricing (GVAP) related activities.
• Work cross functionally with all parts of the business to insure strategic alignment
• Provide expert guidance of design and execution of prospective and retrospective studies to generate real world evidence such as
- Disease natural history
- Patient burden
- Treatment patterns
- Other key clinical and psychosocial factors. '
• Provide expert support for post-hoc analyses of randomized clinical trials evaluating
• Design surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities.
• Develop and validate Patient-Reported Outcome (PRO) and Health-Related Quality of Life (HRQoL) tools
• Support development of Global Value Dossiers by providing consulting and liaising between GMA statistics, Global/Regional Medical Directors, and Global Value Access and Pricing (GVAP.)
• Coordinate with multiple stakeholders to ensure quality and scientific integrity and cost-effectiveness of the field work and other assigned project delivery
• Conduct literature search and provide critical appraisal and synthesis of relevant epidemiological studies to support the objectives of projects.
• Review methodology for scientific meeting abstracts, posters, presentations, publication manuscripts, and commercial information flyers for marketed indications.
• Participate in abstract/manuscript development including providing input to study design, statistical analyses and medical writing, and reviewing and approving the drafts.
• Present relevant study materials to internal and external stakeholders and at scientific conferences.
• Ph.D degree in Epidemiology or Public Health or a relevant discipline, or MD/PharmD with epidemiology research background, or an MA/MS in epidemiology with significant research experiences as an epidemiologist.
• A minimum of 5-7 years of industry experiences in the pharmaceutical industries or biotechnology industries with in-depth knowledge of epidemiology and oncology.
• Experience should include the conduct of outcomes research studies (such as, but not limited to, prospective observational studies, patient-reported outcomes/health-related quality of life assessment), and the communication of study findings to internal and external audiences.
• Demonstrated experience in oncology-related registries and prospective observational studies is highly desirable. (At least 5 years of experience analyzing observational data that includes patient registry data).
• Experience working in both global and regional roles; international experience preferred; Customer-facing experience with payers/HTAs is strongly preferred.
• Thorough understanding of epidemiologic methods, preferably in cancer epidemiology, and up-to-date knowledge of the best practices in industry.
To learn more please apply directly or send your CV to firstname.lastname@example.org