What are the responsibilities and job description for the Director, Clinical Operations position at Gables Search Group?
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
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.
- 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.