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).
• Oversee the development and control of key study documents and plans (e.g., protocols, informed consents, clinical study reports).
• Oversee Trial Master File (TMF) set-up, maintenance, and completeness to ensure inspection readiness.
• Collaborate with relevant functions to support data completeness and accurate reporting.
• 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).
• Serve as the clinical operations' functional representative on cross-functional program teams.
• Provide oversight in the selection, onboarding, training, and performance management of study personnel, CROs, and other vendors.

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 phase 1/2 experience.

Benefits

• merit-based salary increases
• short incentive plan participation
• eligibility for 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 plus 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