Responsibilities Lead multiple late‑stage clinical programs within Sarepta Therapeutics. Provide scientific and strategic leadership for activities in clinical development, including regulatory interactions. Lead projects under the direction of the Head of Clinical Development, support business development, foster innovation, and external collaboration. Manage one or more direct reports and lead the clinical development team for a product. Design and execute projects supporting clinical research programs. Lead the clinical study team in protocol development, monitoring, study reports, training documents, and other regulatory documents. Facilitate clinical development goals and achievement of study quality metrics. Contribute to organization, preparation, and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders. Stay current on regulations, guidelines, and scientific advances in the therapeutic area. Cultivate relationships with external partners such as clinical investigators, clinicians, and scientists to support innovation and business development. Assist with due diligence for business development opportunities. Travel to field sites, internal and external meetings, and conferences as required. Qualifications Doctorate degree (MD, DO, PhD, or PharmD) – MD or DO preferred. At least 15 years of clinical/research experience, with 5 years in industry. Experience as a practicing physician. Strong analytical skills in clinical data (safety and efficacy) and knowledge of biostatistics. Working knowledge of GCP and regulatory requirements for clinical studies. Ability to make independent, timely, and appropriate decisions. Collaborative experience in a fast‑paced, matrix, team‑based environment. Excellent written and verbal communication skills. Intellectual curiosity, flexibility, and persistence. High level of organizational and project management skills. Experience interacting with clinical operations, regulatory, QA, and investigators. Additional Information Position is hybrid, requiring occasional on‑site presence at a Sarepta facility in the United States and attendance at company‑sponsored events. The role may require travel to field sites, meetings, and conferences. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e‑Verify. Salary range: $222,400 - $278,000 per year (commensurate with qualifications and market). Benefits include comprehensive wellness, financial support and caregiver assistance. #J-18808-Ljbffr
Senior Director, Clinical Development
SAREPTA THERAPEUTICS
cambridge, cambridge
Published 4 days ago
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