Associate Medical Director

Reporting to the Clinical Development lead for the therapeutic area, the Associate Medical Director is responsible for assisting with the advancement of our DMD therapy development program, with activities including execution of projects, support for business development, ensuring data quality, and collaboration with internal and external partners. The Associate Medical Director serves as the Medical Monitor for ongoing clinical trials in DMD ensuring compliance with ICH/GCP and federal regulations. The ideal candidate has a doctorate degree (MD, PhD or PharmD) and a passion to further the Sarepta pipeline.

Primary responsibilities include:

• Provide clinical development expertise to assigned clinical development programs
• Help design and draft protocol synopses, clinical trial protocols, protocol amendments, and investigator brochures
• Provide clinical oversight and medical monitoring for one or more clinical studies
• Partner with cross functional team to ensure data quality and integrity, accuracy and interpretability
• Partner with Clinical Operations and provide direction and leadership to Clinical Study Team; accountable to the Global Product Team
• Contribute to regulatory documents such as clinical trial applications, trial disclosures, and clinical study reports
• Analyze and interpret clinical trial data and relevant academic literature
• Establish and maintain positive relationships with clinical trial investigators/physicians, KOL’s and clinical advisors through independent collaborations and scientific meetings
• Provide clinical expertise as needed for business development initiatives
• Provide clinical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development

Desired Education and Skills: 

• Doctoral degree required, training in neurology, pediatrics, or nephrology is a plus
• 0-3 years of hands on pharmaceutical or biotech experience in clinical development, rare/orphan diseases is a plus
• Familiarity with the drug development process and clinical trial design and execution
• Working knowledge of biostatistics, regulatory, clinical pharmacology and genetics
• Excellent interpersonal, written, verbal and visual communication skills
• Proven ability to successfully manage multiple tasks and prioritize accordingly
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Intellectual curiosity, flexibility, and resilience

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.