Medical Director
6 days ago
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
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
- 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.
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