The Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives.
The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research and Legal.
Primary Responsibilities Include :
- Provide clinical leadership and contributes to integration of clinical development process & post-marketing activities and other RWE and HEOR activities
- Contribute to the development of real world evidence strategies for post marketing programs, and health economics and patient outcomes research initiatives
- Contribute to the design and conduct of pharmacoepidemiology studies ( ie studies assessing comparative safety and effectiveness, registries, cohort, surveys, case-control or drug utilization studies).
- Provide medical monitoring of observational studies
- Develop effective relationships with key opinion leaders and decision makers both internally and externally
- Contribute to publication development and other external scientific exchange
- Leads assessment, interpretation & communication of relevant scientific literature; maintains awareness of internal & external data resources & identifies appropriate studies for addressing questions of interest
- Collaborate with other functional groups (PV, Medical Affairs, Commercial, Regulatory Affairs)
- Maintains knowledge & skills on evolving epidemiological, health economics methods, tools & data sources.
- Recognized as an expert and thought leader
- Communicate with external thought leaders
Desired Education and Skills :
- MD with additional Epidemiology / Pharmacoepidemiology / Health Economics graduate education and experience in the pharmaceutical industry.
- Proven experience in epidemiology, health economics or real world evidence including post including a minimum of 10 years’ pharmaceutical industry experience
- Experience with medical monitoring and leading post marketing studies
- Proven RWE experience with claims, EHRs, and prospective data
- Knowledge and experience with PROs and PRO data capture
- Experience contributing the design and implementation of natural history studies and registries in the pharmaceutical industry is required;
experience with rare disease is a plus.
- Strong statistics experience and knowledge
- Ability to effectively work in a cross-functional team environment.
- Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Receives minimal supervision
- Excellent problem solving skills and on time deliverable success
LI-Remote
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