Real World Evidence Clinical Lead - Contractor

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