What are the responsibilities and job description for the Director Clinical Development Operations position at GQR?
Sr/Director, Clinical Development Operations
San Diego, CA | Hybrid / Remote with Travel
A next‑generation RNA therapeutics company in San Diego is exploring interest in a future Director/Senior Director of Clinical Development Operations to lead early‑phase clinical execution for breakthrough cardiovascular programs. This role blends strategic leadership with hands‑on operational ownership in a fast‑moving, high‑innovation environment.
Responsibilities
• Lead strategic planning and execution of early‑phase clinical trials, including first‑in‑human studies
• Build, scale, and shape the clinical operations function from the ground up
• Partner closely with Clinical Development on study design, protocol development, and operational strategy
• Lead cross‑functional planning, timelines, budgets, and risk management
• Manage CROs, vendors, and internal clinical teams to ensure high‑quality, inspection‑ready delivery
• Drive patient‑centric trial design and recruitment strategies
• Guide site feasibility, study start‑up, and global execution
• Manage timelines, budgets, risks, and cross‑functional communication
• Establish and refine processes, tools, and systems to elevate operational excellence
• Partner closely with Clinical Development, Regulatory, CMC, and Preclinical teams
• Support regulatory interactions, data review, and program‑level decision making
Requirements
• BS, advanced degree preferred (PhD/MD)
• 10 years in clinical development/clinical operations within biotech or pharma
• Strong background in cardiology clinical research
• Experience with RNA therapeutics strongly preferred
• Proven leadership in global clinical development execution
• Strategic thinker who’s also comfortable rolling up their sleeves
• Creative, solution‑oriented, and energized by building in ambiguity
• Excellent communication, project management, and stakeholder leadership