Director, Translational Operations and Regulatory Integration

Sarepta Therapeutics; Columbus (OH); Hybrid; USD 176,000 - 221,000; Full time

Benefits offered by this job

Physical and emotional wellness

Financial wellness

Caregiver support

Job summary

Sarepta Therapeutics in the United States is hiring a Director, Translational Operations and Regulatory Integration to lead biomarker and translational plans across gene therapy and novel genetic medicines. You will drive cross-functional execution in Research, Clinical Development, Regulatory Affairs, and external partners.

The role emphasizes regulatory readiness, scalable operating models, risk management, and proactive partnerships with CROs and labs to accelerate program milestones and

Responsibilities

• Lead translational operations and regulatory integration across biomarker and translational plans.
• Drive cross-functional alignment among Research, Clinical Development, Regulatory Affairs, and external partners.
• Develop scalable operating models, governance, and risk management to improve execution.

Job description

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 Director, Translational Operations and Regulatory Integration is a leadership role responsible for enabling the successful execution, regulatory readiness, and operational excellence of Sarepta's Translational Biology portfolio across gene therapy, RNA, and emerging genetic medicine programs. This individual serves as a strategic connector across Research, Translational Biology, Clinical Development, Development Operations, Regulatory Affairs, and external partners to ensure biomarker and translational strategies are translated into actionable, compliant, and execution-ready plans. The role provides leadership for translational operations, regulatory integration activities, and cross-functional program execution, ensuring that key milestones, regulatory commitments, clinical biomarker activities, and organizational priorities remain aligned and on track. The Director identifies risks early, drives mitigation strategies, and establishes scalable operational processes that accelerate decision making, improve execution, and support successful regulatory interactions and submissions. Success in this role requires a unique blend of scientific understanding, operational leadership, strategic thinking, and influence, with the ability to effectively communicate across all levels of the organization and build strong partnerships both internally and externally.

The Opportunity to Make a Difference

Manage the operational strategy and execution of biomarker and translational plans across research (preclinical) and clinical development programs. Drive cross-functional alignment among Research, Clinical Development, Quantitative & Clinical Pharmacology, Regulatory Affairs, Medical Affairs, and other key stakeholders. Establish and advance scalable operating models, governance processes, and risk management strategies that improve organizational effectiveness and execution. Serve as a key partner in preparing for and supporting health authority submissions, inspections, regulatory responses, and post-marketing commitments. May oversee a team or individual contributors while fostering a culture of accountability, collaboration, and continuous improvement. Influence decision making through data-driven insights, operational leadership, and proactive identification of opportunities and risks. Strengthen partnerships with CROs, specialty laboratories, clinical sites, academic collaborators, and alliance partners to deliver high-quality translational outcomes. Champion innovative approaches that accelerate program execution, enhance regulatory readiness, and improve the delivery of translational science across the organization.

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,

#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 $176,400 - $220,500 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 offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.