Associate Director/Director Global Outcomes & RWE Generation
Wilmington, DE, USA | Incyte Corporation
Industry:Pharmaceutical / Biotech
Job Description:96 people have viewed this job
Job Summary(Primary function)
This position provides support to the Head of Global Health Outcomes and Real World Evidence Generation within Global Medical Affairs, in coordination and execution of real-world evidence generation activities.This position will also support the development of epidemiology / pharmaco-epidemiology research that lead to scientific publications and reimbursement dossier development.
This position is responsible for driving cross-functional discussions to ensure that the right clinical value elements are considered in pivotal plans for pipeline agents by developing and executing the Outcomes Research strategy and ensuring coordination with Global Value, Access, & Pricing (GVAP) related activities. The epidemiologist/health outcomes lead is expected to work in a highly collaborative and integrated fashion to efficiently coordinate prospective generation of real world data emanating from external collaborations with external experts (and their institutions & consortia) internationally and the internal communication of such data for vetting and contextual interpretation within Incyte. These data will support critical activities for the preparation for launch of in-clinic agents in the near and intermediate future.
Essential Functions of the Job(Key responsibilities)
• Work closely with the Global Medical Affairs (GMA), Global Product Strategy (GPS), and regional Health Economics & Outcomes (HEOR) departments including medical directors, clinicians, statisticians, statistical programmers, and medical writers to provide scientifically sound epidemiology research strategies across Incyte’s product portfolio.
• Provide expert guidance of design and execution of prospective and retrospective studies to generate real world evidence related to disease natural history, patient burden, treatment patterns, and other key clinical and psychosocial factors.
• Provide expert support for post-hoc analyses of randomized clinical trials evaluating clinical, patient-centered, and/or economic endpoints.
• 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) instruments when necessary.
• 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; be able to identify potential risks and coordinate with involved stakeholders to find timely and effective solutions.
• 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.
• Build relationships and collaborations with leading authorities, academic institutions, and government entities focused in PRO and QOL work.
• Understand and evaluate the needs of multiple stakeholders related to enhancing the value of PROs and QOL in healthcare decision making.
• Establish company leadership by collaborating to enhance the importance and impact of the patient voice in public policy, regulatory approvals and other healthcare decision making.
• Provide internal education related to PRO and QOL initiatives and advise senior leadership.
• Perform all company business in accordance with regulations and company policies and procedures.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• 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 industrial experiences in the pharmaceutical industries or biotechnology industries with in-depth knowledge of epidemiology and oncology. Relevant research experiences in academia will also be considered. Ideally, the candidate has extensive epidemiologic research experiences in the oncology therapeutic area, especially in melanoma, immuno-oncology and/or solid tumors; experience in other therapeutic areas is a plus.
• 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.
• Experience working with CROs, particularly real-world data providers and analytics service providers, and can evaluate vendor products and software for feasibility and applicability to in-house analytic needs.
• 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.
• Understanding of the global and US domestic healthcare and pharmaceutical industry and different data sources.
• Some publications, especially first-authored publications, are expected.
• Excellent oral and written communication skills and ability to work well independently as well as with diverse team members.
• Good organization and project management skills.
• Industrial experiences in working for medical affairs would be considered as a plus.
• Ability to travel domestic and international, when required
Already a member? Sign In