Director, Clinical Development

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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:

The Medical Director is responsible for advancement of Sareptas 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 KOLs 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

Were always looking for solution-oriented critical thinkers.

So if youre 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 Sareptas 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 $238800 - $298500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

Required Experience:

Director