Director, Translational Operations and Regulatory Integration
Core
Strategic leadership for translational operations and regulatory integration across gene therapy, RNA, and genetic medicine programs, ensuring alignment between research, clinical development, and regulatory affairs.
Role type
Director, Translational Operations and Regulatory Integration
Builds
Actionable, compliant, and execution-ready translational strategies and regulatory plans for gene therapy and RNA programs.
Domain
Biotechnology / Gene Therapy / Regulatory Affairs
Required skills
Strategic thinking, operational leadership, risk management, cross-functional alignment, project management, regulatory readiness, stakeholder influence, data-driven decision making, partnership management.
Preferred skills
Advanced degree, experience managing research or development stage programs, scientific acumen in disease biology, quantitative and analytical skills.
Technologies
MS Project, Excel, PowerPoint, Word
Responsibilities
Manage operational strategy and execution of biomarker and translational plans; Drive cross-functional alignment among Research, Clinical Development, and Regulatory Affairs; Establish scalable operating models and governance processes; Support health authority submissions and regulatory responses; Oversee team or individual contributors; Influence decision making through data-driven insights; Strengthen partnerships with CROs and academic collaborators.
Seniority
Director, strategic leadership with hands-on execution