Job title: Real World Evidence Scientific Lead
- Location: Morristown, NJ, Cambridge, MA
Main responsibilities:The Real-World Evidence (RWE) Scientific Lead is an essential scientific position responsible for managing the implementation of cutting-edge, effective, and efficient real world evidence strategy for the development of autoimmune type 1 diabetes (aT1D).
As such, you are responsible for the end-to-end high-quality execution of real-world studies, working in close partnership with the global RWE Strategy aT1D Lead and internal and external cross functional collaborators.
Your main responsibilities are as follows:
- Partner with the Real-World Evidence Strategy AT1D Lead to deliver the value of RWE for the registration, pre-launch and peri-launch of teplizumab in autoimmune type 1 diabetes.
- Manage the end-to-end planning, execution and communication of specific research studies, ensuring that deliverables areon time, within budget, to specification and of high scientific rigor that demonstrates commitment to quality.
- Deliver strategic scientific input in all stages of RWE study conceptualization through study closure, including study design,cohort construction, protocol & statistical analysis plan development, study operations, data analysis, results interpretation and clinical study report development.
- Collaborate with cross-functional stakeholders and relevant internal and external scientific experts based on specific needs of individual RWE studies to ensure that the real-world data and RWE generation is fit-for-purpose to the intended use, whether for regulatory, market access or clinical use.
- Serve as methodological expert in the design and execution of real-world study plans to address critical evidence generation gaps as well as in-house study methodology expert leveraging opportunities to use innovative RWE study designs and analytics to deliver on critical needs.
- Identify and validate external fit-for-purpose data sources, associated institutions and/or organizations, in collaboration with other members of the RWD&ES team.
- Manage the development of budgets for RWE studies in collaboration with relevant internal and externalstakeholders, including RWE Operations, Sanofi Global Hub and/or vendors as appropriate, to support the annual strategic and budget planning process and periodic updates.
- Maintain timely communication and close alignment with team members, partners and stakeholders to ensure clearand timely visibility the evidence strategy, study progress and anticipation of challenges and risk mitigation.
- Accountable for supporting GenMed medical gaps within the Global Integrated Evidence Generation Plans (IEGP).
About YouYou are a self-starter who brings your energy, expertise and experience as well as takes an entrepreneurial approach to solving problems, have a growth mindset and are passionate about unleashing the power of real-world data with data science to improve health.
- Advanced degree in pharmaco-epidemiology, biostatistics, or Health Outcomes (PhD preferred). Education in business is a plus.
- Minimum 5 years in real-world evidence (RWE) generation for pharmaceutical industry with end to end leadership experience
- Strong publication track record in relevant journals.
- Experience across therapeutic areas, including transplant, diabetes, and cardiovascular.
Soft Skills:
- Ability to influence and motivate teams as well as senior leaders.
- Strategic thinking for innovative evidence generation.
- Urgency, ownership, and proactive attitude.
Technical Skills:
- Expertise in pharmacoepidemiology, HEOR, and RWE study design.
- Working with routinely collected healthcare data.
- End-to-end project management for real-world studies.
- Understanding of commercial strategy.
- Fluent English is mandatory, a second European language is appreciated.
The salary range for this position is:
$178,500.00 - $257,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
