Director, Translational Operations and Regulatory Integration

Sarepta Therapeutics•Columbus, OH

2d•Hybrid

About The Position

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.

Requirements

Bachelor's degree required with at least 12+ years of experience, advanced degree preferred, with at least 10+ years of experience in the pharmaceutical, biotech, and/or healthcare industry, with experience in the management of research or development stage programs
Ability to work with and coordinate demands from multiple parties, both internally and with external partners; strong interpersonal skills with the ability to work cross-functionally, manage a crisis, and align the interests of multiple parties.
Superior attention to detail, excellence in project management and ability to effectively manage multiple projects/priorities.
Self-directed individual; ability to work independently with limited direction while working successfully in a cross-functional environment.
Highly collaborative team player who fosters open communication, facilitates mutual understanding and cooperation with all stakeholders.
Comfortable working in or leading matrix teams
Working knowledge of all functional areas of drug development, including: biology, QCP, immunology, clinical development, diagnostic development, etc.
Demonstrated scientific acumen and mechanistic understanding of disease biology
Strong quantitative, reporting and analytical skills
Strong written and verbal communication, negotiation, and presentation skills.
Fluency with standard computer software packages (Word, Excel, PowerPoint, MS Project, etc.).

Nice To Haves

advanced degree preferred

Responsibilities

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.