Director, Clinical Operations

Responsibilities

• Oversee all aspects of clinical development, including research, operations, safety, and portfolio planning
• Supervise and manage the internal clinical team and provide day-to-day mentoring
• Manage clinical site selection, trial agreements, and budget negotiations
• Select and manage vendors such as CROs, central labs, and central IRBs
• Participate in designing and writing clinical trial protocols
• Review and approve clinical study documents including SAP, EDC design, and clinical study reports
• Collaborate with leadership regarding IP formulation, manufacturing schedules, and stability programs
• Conduct investigational product forecasting and management

Requirements

• Bachelor’s degree or higher in Science or Business
• Minimum of 12 years of experience in clinical operations, vendor management, and budget/contract management
• At least 4 years of experience in a services organization, preferably within Pharma, Biotech, or a CRO
• Minimum of 6 years of direct or indirect supervisory experience managing cross-functional teams
• Proven experience with IND and NDA submissions

Preferred Qualifications

• Experience in life sciences, GXP, or government contracting
• Proficiency in MS Office Suite and MS Project

Benefits

• Medical, dental, and vision coverage with prescription benefits
• 401(k) plan with company matching
• Paid vacation, sick leave, holidays, and parental leave
• Company-paid short-term and long-term disability insurance
• Employee assistance program and various voluntary perks including fitness club contributions

About the Company

Meso Scale Diagnostics (MSD) is a leader in providing advanced technologies for the discovery and development of biomarkers. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity.