Associate Director, Patient Centered Outcomes Research

The Associate Director, Patient-Centered Outcomes Research sits within Sarepta’s Global Health Economics, Global Health Outcomes and RWE team, and contributes to both successful development and commercialization of new, innovative therapies for neuromuscular diseases. The successful candidate is assigned to one or more program teams and contributes to program strategies with comprehensive evidence generation plans and research studies that identify clinical and patient-centered unmet needs, as well as values that Sarepta’s treatments provide in addressing those needs. Utilizing their expert understanding of PRO development including knowledge of FDA PRO Guidance, the Associate Director candidate participates in cross-functional discussions to ensure that the right patient and clinical outcome assessments are considered in pivotal plans for Sarepta’s therapies in development and that the right value elements are considered in late stage and post marketing evidence generation plans. This role works closely with GMAX leads, HE leads, Legal, Clinical Development, Regulatory, Commercial and External Vendors. The ideal candidate will have a strong background in health outcomes research, and a working knowledge of health economic analytics and epidemiology within the biotech or pharmaceutical industry.

• Explore the opportunities and challenges of a truly patient centric approach throughout the product lifecycle, starting in early development.
• Manage the incorporation of a PRO strategy into the clinical development, regulatory and market access strategies.
• Provide input and/or review of the relevant sections of the research protocols, statistical analysis plans (SAPs), and other reports.
• Assess literature on the existing patient-centered outcomes, conduct gap analyses and help design activities to address those gaps.
• Support development and validation of PRO/ObsRO and more broadly HRQoL instruments in DMD.
• Lead the development and implementation of outcomes research strategies to support the value proposition of our products.
• Collaborate with cross-functional teams, including clinical development, RWE, medical affairs, market access and commercial teams to incorporate health outcomes research into product development and commercialization strategies.
• Stay current on trends and best practices in health outcomes research to ensure that our research strategies are aligned with industry standards.
• Keep abreast of the evolving regulatory guidance on patient focused drug development, inclusion of patient experience data in regulatory filing dossiers and patient reported outcomes for labelling claims.
• Communicate Patient-Centered Outcomes Research findings from these studies to clinical, scientific, academic, and patient communities in a meaningful way.
• Provide support with execution of other initiatives and research deliverables across the broader team.
• Other related duties as required.

Desired Education and Skills: 

• MSc. or PhD or equivalent in health outcomes research, health economics, epidemiology, or related field.
• At least 8-10 years of experience in health outcomes research within the biotech or pharmaceutical industry.
• Demonstrated track record of leading and executing health outcomes research studies.
• Strong analytical skills in statistical methods for outcomes research.
• Excellent communication and leadership skills with the ability to collaborate effectively with cross-functional teams.
• Must be highly motivated and able to handle multiple tasks to effectively prioritize and meet personal and team goals.
• Ability to manage complexity requiring both strategic and tactical skills.
• Strong strategic thinking skills with a demonstrated ability to identify business issues/opportunities.

This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

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