Senior Medical Director - IPF

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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 Opportunity to Make a Difference

• Leads the clinical development team for a product, which may include one or more direct reports.
• Design and execute projects supporting clinical research programs.
• Leads the clinical study team to ensure success protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents.
• Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders.
• Can effectively work across multiple projects within a designated therapeutic area.
• Represents development sciences on governance committee for projects.
• Represents the company in high-level interactions with regulatory agencies and industry stakeholders.
• Interacts with internal and external executive level management, requiring negotiation of extremely critical matters.
• Stay updated on regulations and guidelines for their therapeutic area and scientific advances in the relevant field both internal and external to Sarepta.
• Cultivates relationships with external partners such as clinical investigators, clinicians, and scientists in support of innovation and business development.
• Assist with the due diligence for business development opportunities.

More about You

• MD or PhD required, subspecialty training in relevant therapy preferred.
• 6-8 years of hands on pharmaceutical or biotech experience in clinical development; relevant therapy 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.
• Recognized by former peers, colleagues, managers, and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.

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.