The ED Functional Outcomes Lead at Sarepta is responsible for overseeing the selection, implementation, and interpretation of functional outcome measurements across the company's development portfolio, with a focus on maximizing signal-to-noise ratio while balancing patient and investigator burden and costs. The role involves complementing traditional outcomes with newer measurements, collaborating externally to obtain relevant datasets, and partnering with the medical director to select appropriate functional efficacy endpoints for trial protocol. The Lead will co-author, review and/or approve key regulatory documents, collaborate with development operations to enhance data quality through training and monitoring, and contribute to scientific communications for the publication of functional outcomes data. The ideal candidate has a doctorate in a relevant field, over 10 years of experience in clinical research or industry, expertise in functional outcomes, and strong analytical, communication, and project management skills.

Primary Responsibilities Include:

•  The ED Functional Outcomes Lead will have the overall responsibility for selection, implementation, and interpretation of functional outcome measurements across the Sarepta Development Portfolio.
• The lead is expected to have a deep understanding of the strengths and limitation of functional outcome measurement in clinical trials and be able to select an appropriate program of measurements that maximize signal to noise while balancing patient and investigator burden and costs.
• The lead will be responsible for complementing traditional functional outcomes with newer measurements (e.g. wearables) and collaborating externally with other experts to obtain appropriate natural history datasets to facilitate their interpretation.
• Partner with the medical director on the selection of appropriate functional efficacy endpoints across programs
• Author, review and/or approve relevant sections of the protocol, CSR and other regulatory documents, e.g. schedule of event for functional outcome assessment, study assessments, etc
• Partner with development operations and QC to develop the appropriate site training materials and monitoring program to elevate quality of data generated from functional endpoint
• Member of key CSTs and associated governance bodies (e.g. CSOC) as determined by VP clinical development
• Lead review of new endpoints including possible validation efforts
• Partner with scientific communications to ensure prompt and high-quality presentation and publication of Sarepta data and experience as it relates to functional outcomes

Desired Education and Skills: 

• Clear academic and/or industry derived expertise in the selection, administration and interpretation of functional outcomes in one or more of Sarepta clinical therapy areas of focus
• Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Ability to make independent, timely, and risk-based decisions
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Excellent written and verbal communication skills
• Intellectual curiosity, flexibility, and persistence
• High level of organizational and project management skills
• Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators within an academic or industry environment
• Has at least 10 years of clinical research and/or industry experience
• Doctorate degree: MD, Ph.D. or Pharm D in a related area

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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.

The targeted salary range for this position is $235,600 - $294,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

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.