Cambridge, MA / Bridgewater, NJ, US.
This role will be responsible for development of oversight of Health Economic and Outcomes Research (HEOR) strategy to support the value proposition of Tolebrutinib and Early Neurology/Immunology indications. The incumbent interfaces with Clinical, Medical Affairs and business partners including Global and US Commercial team and Market Access. The role is accountable for the planning, design, implementation, and completion of innovative evidence-based research programs that are consistent with program/product strategies. The research programs developed will provide appropriate evidence and/or tools to be used for internal decision making and for external audiences at product launch and over product life cycle.
- This role will be responsible for the design and execution of Health Economic and Outcomes Research (HEOR) research in the forms of economic modeling, database analysis, observational research, Clinical Outcomes Assessment (COA) development and validation, systematic literature review, evidence synthesis, value dossier development and other types of HEOR research, and provide trial design recommendations.
- This role will set the HEOR evidence generation priorities and plan for the assigned indications in life cycle or under development and incorporate them into broader Sanofi planning documents such as the integrated evidence generation plan (IEGP).
- This role will operate as part of a multi-functional global Brand team and Development team that is responsible for designing clinical research programs to meet the evidentiary standards of regulators, health technology assessment (HTA) organizations, reimbursement authorities, third-party payers and other organizations that review evidence relevant to Sanofi medicines.
- This role will develop collaborative research relationships, (e.g. payers) that inform value to decision makers. This role will leverage interactions to identify strategies that will improve the impact of research and build advocates for data.
- This role will serve as a subject matter expert to provide input in various commercial, medical, market access teams, and strategy development
- This role is expected to demonstrate effective communication, organizational and interpersonal skills to be able to work effectively as part of a multidisciplinary team. The incumbent is expected to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law.
Key Stakeholders
Internal
- Market Access & Pricing, Global, US and affiliates
- Cross functional Brand team
- Medical Affairs – GBUs, affiliates, HEVA RW Evidence and Analytics, Clinical Outcomes Generation
- Commercial team
- R&D – Global project teams and Clinical Affairs, COA and HVT
- Public Affairs, Communications
- Regulatory Affairs, Compliance and Legal
External
Key Performance Indicators
- Timely design and execution of the HEVA plan
- Demonstrated contributions to product success
- Development and execution of strategies that address data gaps and customer needs
- Expertise recognized within the function
- Develops and maintains peer relationships with clinical and economic methods
- Anticipates communication needs to cross-functional audiences and pre-empts issues with timely and effective action
- Established track record of scientific and/or methods publications in peer-reviewed journals
- Compliance with all relevant internal SOPs and external laws and regulations.
About you
- Advanced degree (PhD, MD, MS, MPH, or PharmD) in a scientific discipline
- Minimum of 3 years of combined experience in health economics, outcomes research, or a related field
- Demonstrated experience in applying various HEOR methods to specific research projects.
- Proficiency in principles of evidence-based medicine and clinical research methodology. Understands, creates, and applies relevant methods (e.g., observational data, post hoc analysis of clinical trials, meta-analysis, indirect comparison, etc..) to demonstrate product value potential
- Has US or global product launch experience, understand US or global payer evidence requirements and value demonstration in a competitive market
- Has experience in translating Target Value Propositions and access strategies into evidence hypotheses, requirements and generation plans addressing payer/provider/health system unmet needs
- Understands the risks and opportunities deriving from generating Real World Evidence
- Publication in peer-reviewed journals
- Knowledge of global HTA processes and guidelines, experience with HTA submissions preferred
- Knowledge of US payers and guidelines, experience with US submissions preferred
- Strong ability to partner with colleagues from other (i.e. non-HEOR) functional areas
- Demonstrated understanding disease physiopathology, drug mechanism of action, clinical development principles, epidemiology, biostatistics, statistical programming COA development, systemic literature reviews, and network meta-analyses
Skills & Competencies
- English fluent, both written and oral
- Strong communication skills, both verbal and written, including presentation skills. Significant experience making presentations to senior management is strongly desired
- Understanding of the legal and regulatory environment of the pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics
- Entrepreneurial and team spirit and ability to develop creative solutions to complex problems
Sanofi Specialty Care has pioneered the development and delivery of transformative therapies for patients affected by debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, neurologyand onco-immunology, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi Specialty Care’s portfolio of transformative therapies, which are marketed in countries around the world, represent ground-breaking and life-saving advances in medicine. Sanofi Specialty Care employees benefit from the reach and resources of one of the world’s largest pharmaceutical companies with a shared commitment to improving the lives of patients.
HEVA’s mission of conducting, communicating, and translating evidence to demonstrate the value of Sanofi’s products and support optimal access and treatment outcomes for patients. The Immunology HEVA team is responsible for designing and fulfilling evidence generation plans that meet the strategic goals of Immunology portfolio.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 Days Prior To Start Date.
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