Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit www.sarepta.com.
The Executive Medical Director is responsible for assisting with the advancement of assigned gene therapy clinical development programs. The Executive Medical Director supports the strategic, clinical and regulatory aspects of assigned programs and serves as the Medical Monitor for assigned clinical trials in DMD, ensuring compliance with ICH/GCP and federal regulations.
Primary responsibilities include:
Provide Medical and Clinical Development expertise and leadership to assigned gene therapyclinical development programs
Design and draft clinical development plans, protocol synopses, clinical trial protocols and protocol amendments. Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues
Partner with Clinical Operations and provide leadership and direction to clinical project teams
Establish and maintain positive relationships with clinical trial investigators/physicians, KOL's and clinical advisors through independent collaborations and scientific meetings
Support Data Monitoring Committee's during the conduct of clinical trials
Provide clinical development support for regulatory agency engagements and documents including INDs and BLAs
Provide strategic input on compounds in development and propose clinical development strategies
Provide medical expertise as needed for business development initiatives
Provide medical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development
Education and Skills Requirements:
MD required, subspecialty training in neurology or pediatrics is preferred
8+ years of hands on pharmaceutical or biotech experience in clinical development. Rare/orphan diseases preferred, but not required
Strong immunology and/or gene therapy background is highly preferred
Prior IND/CTA and/or NDA/MAA filing experience
In depth knowledge of drug development process and oversight of clinical trials
Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
Excellent interpersonal, written, verbal and visual communication skills
Proven ability to successfully manage multiple tasks and prioritize accordingly
Professional and pleasant demeanor
Willingness to travel
Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion
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.