Job Title: Director, Clinical Development Operations Program Lead

Work Location: Middlesex County, Massachusetts (1x a week onsite)

Summary:

The Director, Clinical Development Operations Program Lead is responsible for overseeing the operational execution of clinical development programs from start to finish. This role acts as the primary operational lead at the program level, translating clinical development strategies into actionable global plans and ensuring the timely and high-quality achievement of clinical milestones. The position requires a strategic and execution-focused mindset, proactive risk management, and leadership in a highly outsourced environment.

Responsibilities:

• Lead the creation and execution of integrated operational plans for clinical development programs, ensuring alignment with strategic objectives.
• Translate clinical development strategies into detailed operational plans, timelines, and resource models, collaborating with cross-functional teams.
• Identify, assess, and manage program-level risks and dependencies, escalating issues and proposing mitigations as needed.
• Oversee performance metrics for CROs, vendors, and sites, ensuring accountability for quality, timelines, and budget adherence.
• Provide leadership to operational teams, fostering collaboration and accountability across internal and external stakeholders.
• Support the development and monitoring of program-level clinical budgets, ensuring alignment with operational plans and priorities.
• Deliver comprehensive program-level operational status reports, including timelines, risks, and key trade-offs, and prepare materials for governance forums.
• Ensure program readiness for audits and inspections by maintaining clear documentation and supporting onboarding of new team members and partners.

Qualifications:

• Bachelor’s degree required; advanced degree preferred.
• 10+ years of experience in clinical operations and clinical development operations program management, including hands-on trial management and a strong understanding of the end-to-end drug development process.
• Demonstrated experience leading clinical programs in an outsourced CRO model.
• Strategic mindset with proactive risk management and a solution/results-oriented approach.
• Strong knowledge of GCP, global regulatory requirements, and inspection-readiness expectations.
• Proven ability to work cross-functionally, lead with influence, and motivate others.
• Excellent communication, organizational, and problem-solving skills.
• Ability to operate independently, manage complexity, and drive execution in a fast-paced environment.
• Willingness to travel as needed (approximately 15%).

Published Category: Clinical Operations & Development