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Associate Medical Director Jobs
Company | Sarepta Therapeutics |
Address | , Cambridge, 02142, Ma |
Employment type | FULL_TIME |
Salary | $156,000 - $195,000 a year |
Expires | 2023-06-10 |
Posted at | 1 year ago |
Reporting to the Clinical Development lead for the program, the Associate Medical Director is responsible for assisting with the advancement of our DMD gene 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 proven success in clinical development through industry experience and a passion to further the Sarepta pipeline.
Primary responsibilities include:
- Help design and draft protocol synopses, clinical trial protocols, protocol amendments, and investigator brochures
- Partner with Clinical Operations and provide direction and leadership to clinical project teams
- Contribute to regulatory documents such as clinical trial applications, trial disclosures, and clinical study reports
- Establish and maintain positive relationships with clinical trial investigators/physicians, KOL’s and clinical advisors through independent collaborations and scientific meetings
- Provide clinical development expertise to assigned clinical development programs
- Provide clinical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development
- Provide clinical expertise as needed for business development initiatives
- Provide clinical oversight of multiple clinical studies, input and guidance on scientific, clinical and safety monitoring issues
- Provide strategic input on compounds in development and propose clinical development strategies
Desired Education and Skills:
- Excellent interpersonal, written, verbal and visual communication skills
- MD or PhD required, training in neurology, pediatrics, immunology, or genetics is a plus
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- Knowledge of drug development process and oversight of clinical trials
- Working knowledge of biostatistics, regulatory, clinical pharmacology and genetics
- Proven ability to successfully manage multiple tasks and prioritize accordingly
- 0-3 years of hands on pharmaceutical or biotech experience in clinical development, rare/orphan diseases preferred, but not required
- Excellent written and verbal communication skills
- Intellectual curiosity, flexibility, and persistence
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.
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