The Associate Medical Director is responsible for assisting with the advancement of our DMD PPMO therapy development programs. The Associate Medical Director serves as the Medical Monitor for ongoing clinical trials in DMD ensuring compliance with ICH/GCP and federal regulations.
Primary responsibilities include:
Provide clinical development expertise and leadership to assigned clinical development programs
Help design and draft protocol synopses, clinical trial protocols, protocol amendments and provide clinical oversight of multiple clinical studies, 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
Provide strategic input on compounds in development and propose clinical development strategies
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
Education and Skills Requirements:
MD or PhD required, subspecialty training in neurology or pediatrics is preferred
0-3 years of hands on pharmaceutical or biotech experience in clinical development, rare/orphan diseases preferred, but not required
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.