The Importance of the Role The Medical Director is responsible for advancement of Sarepta's clinical-stage programs. The individual is responsible for defining strategic priorities for the program and integrating cross-functional input in order to develop and execute the clinical development plan. They will be called upon to represent clinical development on the clinical study team, which drives program development, approval, and commercialization of the asset. The individual must have strong team leadership skills and have deep knowledge of the clinical drug development process, spanning early/translational phases through to registration.
The Opportunity to Make a Difference - Function as the clinical development leader to create and execute a clinical development plan that provides strategic priorities and solutions to program challenges.
- Partner with cross-functional leaders and governance bodies to provide leadership and direction to support the clinical development plan and drive cross-functional decision making.
- Establish and maintaining positive relationships with clinical trial investigators/physicians, KOL's and clinical advisors through independent collaborations and scientific meetings.
- Provide expertise and leadership to support protocol development, regulatory agency engagements, and documents including INDs and NDAs.
- Provide clinical oversight and medical monitoring for clinical trials; ensuring patient safety, protocol adherence, data quality and integrity, and compliance with ICH/GCP and regulatory requirements.
- Analyze, interpret, and contextualize clinical trial data to support program-level decision making
More about You Desired Education and Skills: - MD or PhD required, subspecialty training in neurology is preferred.
- 6-8+ years of hands on pharmaceutical or biotech experience in clinical development; Rare/orphan diseases preferred, but not required.
- 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.
- Proven ability to interact cross-functionally with strong presentation skills.
- Willingness to travel.
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- Intellectual curiosity, flexibility, drive, and resilience
What Now? We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid
This position is hybrid, 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 $238,800 - $298,500 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.
