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 Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.