Director, Clinical Operations

Why join Freenome?

Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. 

To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

To fight the war on cancer, Freenome has raised more than $1.1B from leading investors including a16z, GV (formerly Google Ventures), T. Rowe Price, BainCapital, Perceptive Advisors, RA Capital Management, Roche, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures. 

Are you ready for the fight? A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrive in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. Freenomers are determined, patient-centric, and outcomes-driven. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. We are dedicated to advancing healthcare, one breakthrough at a time.

About this opportunity:

Freenome’s Director, Clinical Operations will provide clinical operations leadership, define the Clinical Operations organization infrastructure, and execute clinical study programs.  Critical accountabilities include devising strategic and tactical plans for executing pivotal clinical studies.  This role will also manage program timelines, department budgets, key objectives, and manage and develop the  Clinical Operations team. The role reports to the Senior Director Clinical Development.

What you’ll do:

• Provide clinical study operations leadership for large-scale, fast enrolling, and biospecimen centered clinical trials for IVD development.
• Manage operational plans and timelines to achieve on-time enrollment and study completion.
• CRO management, site operations/monitoring, and data delivery milestones in line with corporate goals.
• Identify barriers to timely and successful study execution and propose solutions, with regular reporting of program performance metrics.
• Manage a small but growing Clinical Operations team, ensuring development, engagement, and training opportunities.
• Lead initiatives to improve systems, processes, procedures to drive quality into Clinical operations, including GCP training programs, SOP gap-assessments/overhaul projects, and rigorous internal audit plans.
  Develop communication strategies to work cross-functionally effectively in project team situations to influence, collaborate, and meet the needs of internal and external stakeholders.
• Collaborate with senior management to develop project timelines, study budgets, and report periodically on project status to all stakeholders.
• Oversee and manage all operational aspects at the Clinical Program level, including investigator selection, analysis, and KOL collaborator engagement.
• Prepare study-related documentation, including protocols, case report forms, consent documents, clinical trial agreements, project management plans, etc.
• Collaborate with internal cross-functional teams on assay development activities
• Ensure compliance with all regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA, and applicable international regulations concerning clinical activities.

Must haves:

• Undergraduate degree, advanced degree /or additional coursework in clinical trial planning and execution preferred.
• Minimum of 10 years of clinical trial management experience in the pharmaceutical, biotech, or diagnostic industry, preferably in vitro diagnostics (IVD).
• Clinical experience with large scale oncology trials.
• Experience in building and managing a high performing Clinical Team.
• Data management experience and knowledge of statistical principles as applied to clinical trials.
• Strong track record of management of clinical study operations staff and team leadership.
• Thorough knowledge of GCP, ICH guidelines, and US and international clinical regulatory requirements.
• Ability to develop positive working relationships with individuals and t