Our client, a small oncology-focused biotech company is currently looking for an experienced Director, Clinical Operations (contract) to join their dedicated team.

Candidates located in San Francisco and San Diego is highly preferred!

• 6-month contract, 40 hours per week. (contract could potentially be extended/converted to permanent employee)
• Fully remote (must be located in the Pacific or Mountain time zone - this is required)
• The hourly rate is based on employment options (1099 or W2 contract) and based on experience.

Responsibilities:

• Lead and oversee Study Execution Teams (SETs), offering therapeutic expertise and guidance to ensure trials are initiated and completed on schedule, within budget, and in alignment with SOPs, FDA regulations, and ICH/GCP guidelines.
• Leverage extensive experience in evaluating and managing CROs and vendors, serving as the primary escalation contact and as the program representative in vendor oversight and governance meetings.
• Oversee program execution, proactively identifying and addressing risks to study initiation, enrollment, quality control, and completion.
• Maintain comprehensive command of program status, communicating any potential impacts on quality, timelines, or costs to senior management and key stakeholders.
• Collaborate with cross-functional stakeholders to address and remove barriers, ensuring that timelines and objectives are met.
• Act as a Clinical Operations representative on the Clinical Development Execution Team (CDET) and Project Team, collaborating on Clinical Development Plans, operational strategy (site selection, enrollment, data collection, monitoring), and the delivery of high-quality data.
• Lead the development and support of work instructions and SOPs, drive Clinical Operations functional initiatives, and contribute to cross-functional initiatives as needed.

Requirements:

• Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree in a relevant scientific discipline is preferred
• A minimum of 12 years of experience with expertise in the areas of clinical operations with 8+ years of leadership experience
• Experience planning, implementing, and conducting early to late stage oncology clinical trials
• 4+ years of direct line management experience
• Experience working within a small biotech company preferred
• Proven experience in developing high performance clinical operations group; setting expectations, creating accountabilities, and leading the team to successfully achieve its objectives