Real World Evidence Scientific Lead
We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence, and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world.
The Real-World Data & Evidence Science (RWD&ES) team, in General Medicines Medical, serves as an end-to-end strategy and execution partner to solve business problems using real-world data. We partner with cross-functional teams to lead the planning and execution of real-world evidence (RWE) strategies.
About the role
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). You will work in close partnership with the global RWE Strategy aT1D Lead and internal and external cross-functional collaborators to ensure end-to-end high-quality execution of real-world studies.
Responsibilities
- 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 deliverables are on time, within budget, to specification, and of high scientific rigor.
- 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 to ensure real-world data and RWE generation is fit-for-purpose for the intended use, whether for regulatory, market access, or clinical use.
- Serve as a methodological expert in the design and execution of real-world study plans to address critical evidence generation gaps and leverage innovative RWE study designs and analytics.
- 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 external stakeholders to support annual strategic and budget planning.
- Maintain timely communication and close alignment with team members, partners, and stakeholders to ensure clear visibility of the evidence strategy, study progress, and risk mitigation.
- Accountable for supporting GenMed medical gaps within the Global Integrated Evidence Generation Plans (IEGP).
Qualifications
- 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 the pharmaceutical industry with end-to-end leadership experience.
- Strong publication track record in relevant journals.
- Experience across therapeutic areas, including transplant, diabetes, and cardiovascular.
Skills
- 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.
Benefits
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether through promotion or lateral moves, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family with a wide range of health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies reflecting real-world needs.
- Help improve the lives of millions globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.