Dir Health Economics & Outcomes Research
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Sleepy Hollow, New York
- Start date
- Sep 19, 2023
View more
- Discipline
- Regulatory, Research/Documentation, Science/R&D, Research
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
As a Director, HEOR you will develop and implement global and regional HEOR strategies and programs for Regenerons oncologic products, with the aim to inform and support clinical development needs during early pipeline phase. We collaborate with business partners to develop and support compelling product value propositions with aim to optimize future patient access to Regenerons therapies.
A typical day may include the following:
Identify HEOR evidence requirements and gaps, and design, conduct, and deliver studies and tools to support relative value demonstration and product differentiation
Leverage RWD analytic tools and collaborate with Real World Data & Analytics (RWDnA) team on generating insights to inform development programs.
Co-lead conduct of regulatory-grade real world evidence studies and provide education on emerging opportunities for using RWE across solid tumor portfolio.
Collaborate on conduct and communication of epidemiology and pharmacoepidemiology analyses and studies supporting development and regulatory 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 future patient access
Develop and implement Clinical Outcomes Assessment (COA) measurement strategies and plans in support of 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. Interact as necessary with Agencies on those matters and keep track of competitor PRO developments with regulators.
Evaluate relevant payer and health technology assessment (HTA) decisions, collect feedback in advisory meetings and apply key findings to pipeline products.
Maintain an up-to-date awareness of regulatory and payer/HTA considerations that may impact planning for implementation of HEOR programs.
Report, publish and disseminate HEOR data and study results in compliance with company, industry, and regulatory requirements.
This may be for you if you:
Are passionate about the impact HEOR has in the drug development process.
Can demonstrate building global relationships
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 an advanced graduate degree (Ph.D., MS, or MD, PharmD., B.Pharm with Masters degree) in HEOR-related field. 7+ years with PhD or 9+ years with MS in HEOR is required at least 3 years of life science company with healthcare consulting experience is a plus. Technical expertise required in design and conduct of HEOR studies and models as is knowledge of regulatory (e.g., FDA, EMA) and HTA considerations in the evaluation of patient-reported outcomes in clinical trials. Strong publication track record in HEOR/COA area. Oncology HEOR experience is preferred.
#HEOR #LI-onsite
Salary Range (annually)
$193,200.00 - $322,000.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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