Director Clinical Operations

Director Clinical Operations

Los Angeles, CA - Hybrid

200,000-230,000

A LA based biotech company is expanding its team to further its mission of revolutionizing cancer treatment through innovative gene therapies. This company is at the forefront of developing off-the-shelf, systemic cancer immunotherapies that harness the power of the immune system to target and destroy cancer cells, offering a transformative approach to oncology.

The leadership team is exceptional. The COO brings extensive experience from leading pharmaceutical companies, and the clinical lead has over 30 years of experience, including several FDA-approved cancer drugs and has filed over 20 US INDs.

This year, they have made significant strides with their first IND submission and have multiple promising candidates in their pipeline. With secure funding, they are well-positioned to make a significant impact in the field of gene therapy.

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 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.

If you are interested, don't hesitate to apply!