Job Description

Director Clinical Operations

San Francisco, CA - Hybrid

$210,000- $240,000

We are partnered with an innovative Biotechnology company that is looking for their next Director of Clinical Operations. They have a robust pipeline of early to mid-phase trials and are in need of expanding their team. Although a newer company on the scene they have strong leadership who have gotten other products approved previously. This is a great opportunity to join a cutting-edge company with high potential at the ground floor.

Responsibilities

• Oversee program management, including risk identification and mitigation, patient enrollment, quality oversight, and study completion.
• Coach and mentor both direct and indirect reports, as well as recruit, hire, and develop new clinical operations team members.
• Evaluate and manage Contract Research Organizations (CROs) and other service providers, serving as the primary point of contact.
• Oversee the selection, contracting, and budget management for vendors and clinical trial sites.
• Provide strategic, tactical, and operational input to cross-functional teams.
• Manage all budgetary activities for assigned programs, including project budget creation, forecasting, accruals reporting, and invoice approval.
• Plan and implement quality checks for multiple clinical trials.
• Develop and support the creation of work instructions and Standard Operating Procedures (SOPs).

Qualifications:

• Minimum of a BA/BS in a scientific or health-related field.
• At least 8 years of experience in Oncology/Autoimmune/Aeurology clinical operations within the pharmaceutical or biotech industry.
• Strong knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
• Excellent leadership, organizational, and communication skills.
• Proficiency in using Microsoft Office applications.

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