Director, Clinical Operations

My client is expanding and seeks a Director, Clinical Operations to oversee clinical development, vendor relationships, site selection and management, and contract and budget negotiations.


This person will take on the following responsibilities:
• Lead and develop a clinical team while contributing to the design and authorship of clinical trial protocols.
• Drive clinical site identification and selection, execute trial agreements, and oversee budget negotiations.
• Identify, onboard, and manage external partners including CROs, central IRBs, and clinical and analytical labs.
• Own vendor contract negotiations and budget management across the full lifecycle of clinical trials.
• Lead investigational product forecasting and inventory management.
• Review and approve clinical study documentation including SAPs, EDC design, validation and edit specifications, clinical study reports, and more.

The ideal candidate will possess the following qualities:
• Bachelor's degree and 12+ years of progressive experience in clinical operations, including expertise in vendor management and contract and budget oversight.
• 4+ years of experience within a services organization , ideally a pharmaceutical, biotechnology, or contract research organization.
• 6+ years of experience leading teams and managing complex, cross-functional projects.
• Hands-on experience with IND and NDA submissions.
• Strong analytical and critical thinking skills with a track record of sound judgment in fast-paced, deadline-driven environments.
• Proven leadership capability with a coaching mindset and a consistently collaborative, supportive approach to developing others.
• Skilled relationship builder who operates with a high degree of professionalism, tact, and discretion across all organizational levels.
• Exceptional written and verbal communication skills with the ability to engage effectively with internal teams and external stakeholders alike.