Director of Clinical Operations
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.
About the Role:
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.
How you’ll contribute:
- 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.
What you bring:
- 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 teams internally and externally.
- Ability to work independently as well as part of a cross-functional team.
- Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills.
- Ability to travel as required (~25%)
As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy. If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster. If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures.
A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time.
Benefits include but are not limited to:
- Competitive compensation
- Pre-IPO equity
- Flexible PTO (exempt) and generous PTO (non-exempt)
- Comprehensive health coverage, including medical, dental, and vision
- Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
- 401(k) plan
- $250.00 new hire stipend to enhance your home office experience
- Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts
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Notice to agencies:
Our in-house Talent Acquisition Team manages all employment opportunities at Freenome. Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee.
We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.
Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.
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