As an Associate Director, HEOR you will develop and implement global and regional HEOR strategies and programs for Regeneron’s oncologic products. We aim to inform and support clinical development and regulatory needs during early pipeline phase.
A typical day may include the following:
Collaborating to develop and support compelling product value propositions to optimize future patient access.
Identifying HEOR evidence requirements and gaps, and design, conduct, and deliver studies and tools to support relative value demonstration and our product differentiation. These would include: prospective and retrospective observational studies, patient experience/preference data generation, early cost effectiveness and budget impact models).
Using RWD analytic tools and collaborate with the RWD & Analytics team generating our insights to inform development programs.
Co-lead conduct of regulatory-grade real world evidence studies and provide education on emerging opportunities for using RWE.
Supporting development of RWD partnerships in oncology.
Collaborating on conduct and communication of epidemiology and pharmacoepidemiology analyses and studies. These are to include prevalence and incidence of disease, natural history of disease, prescribing and treatment patterns, comparative effectiveness in support of our goals.
Provide relevant input into selection of patient population and comparators within clinical trials to enable demonstration of robust incremental clinical value over standard of care that can facilitate optimal patient access
Develop and implement Clinical Outcomes Assessment (COA) measurement strategies and plans supporting product labeling, patient access and product differentiation. Develop and validate COA endpoints for integration in clinical studies; analyze and communicate data from clinical trials. Produce COA evidence dossiers for regulatory submissions (FDA, EMA). Interact as with Agencies and keep track of competitor PRO developments with regulators.
Evaluating relevant payer and health technology assessment (HTA) decisions, collect feedback in advisory meetings and apply key findings to pipeline products.
Maintaining an up-to-date awareness of regulatory and payer/HTA considerations that may impact planning for and implementation of HEOR programs.
Identifying and maintaining successful research relationships with HEOR key opinion leaders and thought leaders.
Reporting, publishing and disseminating HEOR data and study results in compliance with company, industry and regulatory requirements.
Work with Alliance partners on HEOR plans, studies and deliverables; build and maintain constructive and productive relationships across Alliance.
This may be for you if:
• Are passionate about the impact HEOR has in the drug development process.
• Are at ease with an abundance of detail and complexity, yet mindful of the big picture.
• Ability to interact with and present to Senior Management.
• Can work well in a ‘rapid response” environment
To be considered you are required to have a graduate degree (Ph.D., MS, or MD, PharmD., B.Pharm, RN with Master’s degree) in HEOR-related field (e.g. health economics, outcomes research, health services research, statistics, mathematics, pharmacoepidemiology/epidemiology). A minimum of 7+ years with PhD or 9+ years with MS in HEOR within the pharmaceutical or life sciences industry. Strong technical expertise required in design and conduct of HEOR studies and models. Solid understanding of regulatory (e.g. FDA) and HTA considerations in the evaluation of patient-reported outcomes. Experience in design and implementation of patient-reported data in clinical trials, including experience in analysis and reporting of data. At least 2 years of Oncology HEOR experience is a preferred. Strong publication track record in HEOR/COA area.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.