Director, Clinical Operations

1w1 week ago

Meso Scale Diagnostics, LLC

Rockville, US · Full-time · $151,400 – $236,600

About this role

This director level position oversees all aspects of clinical development, including clinical research, operations, safety, and portfolio planning. The role manages vendor relationships, site selection and management, and contract and budget negotiations. It serves as a member of the Clinical Therapeutics leadership team, providing input on department strategies, budgets, and plans.

Day-to-day responsibilities include supervising the internal clinical team and participating in designing clinical trial protocols. Manage clinical site selection, trial agreements, budget negotiations, and vendor oversight for CROs, central labs, and IRBs. Conduct investigational product forecasting, negotiate contracts throughout trial lifecycles, and review study documents like SAPs, EDC designs, and CRFs.

Collaborate with the Executive Director on IP formulation, manufacturing schedules, and stability programs while providing Investigational Brochure input. Operate in a fast-paced, deadline-driven environment requiring critical thinking, sound judgment, and strong leadership. Build relationships through trust, tact, and effective communication across all levels.

Manage aspects of the compassionate use program and contribute to overall clinical strategies. Demonstrate proficiency in MSD Office Suite and MS Project. Foster staff development through guidance, performance management, and clear goal communication.

Requirements

Bachelor’s degree or higher in Science or Business
Minimum of 12 years of experience in clinical operations, vendor selection and management, budget and contract management
At least 4 years of experience in a services organization preferably at a Pharmaceutical or Biotechnology Company or CRO
Minimum 6 years of direct or indirect supervisory experience managing cross-functional teams
Experience in life sciences, GXP, government contracting or other regulated industry
Experience with submissions of Investigational New Drug (IND) applications and New Drug Applications (NDA)
Demonstrated critical thinking, analytical skills, and ability to handle complex situations
Strong leadership skills with knowledge of staff management practices and performance management

Responsibilities

Supervise and manage the internal clinical team
Participate in designing and writing clinical trial protocols
Manage clinical site selection, trial agreements, and budget negotiations
Select and manage vendors required for clinical trials including CROs, central labs, and IRBs
Negotiate vendor contracts and budgets throughout the lifecycle of clinical trials
Conduct investigational product forecasting and management
Review and approve clinical study documents including SAP, EDC design, CRFs, and study reports
Collaborate with Executive Director regarding IP formulation, manufacturing schedule, and stability programs