Clinical Trials Management Director

Role Overview

Direct the end-to-end planning, execution, monitoring, and successful completion of one or more clinical studies within a program(s), ensuring adherence to timelines, budgets, and quality standards. Oversee the development and control of key study documents and plans, and oversee Trial Master File (TMF) set-up, maintenance, and completeness.

What You Will Do

Proactively identify, manage, and mitigate study/program risks and issues; lead quality and compliance activities with cross-functional teams and vendors to drive continuous improvement. Develop, manage, and refine budgets, forecasts, and financial reporting for the assigned program(s).

Why It Might Be a Fit

Provide subject matter expertise for departmental initiatives and process improvement efforts; contribute to the development and refinement of clinical operations policies, procedures, and resourcing strategies. Manage direct reports through coaching, mentorship, and performance feedback.

Requirements

• Bachelor’s or advanced degree, preferably in life sciences, pharmacy, or a related field.
• Minimum 10–15 years (without Master’s) or 8–12 years (with Master’s) of relevant experience in biotech/pharmaceutical or CRO setting, with experience supporting Phases 1–4 clinical studies.
• Experience managing global patient population studies.
• Therapeutic experience working with stem cells and regenerative medicine.
• Strong phase1/2 experience.

Benefits

• Merit-based salary increases
• Short incentive plan participation
• 401(k) plan
• Medical, dental, vision, life and disability insurances
• Leaves provided in line with your work state
• Flexible paid time off
• 11 paid holidays
• Additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter