What are the responsibilities and job description for the Director, Clinical Operations position at Food Management Search?
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.