Clinical Program Manager

About 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.

About the Role 

Freenome’s Clinical Program Manager will lead the design and strategic execution of clinical programs from concept through publication. Key accountabilities include the successful conduct of clinical programs, management of clinical project timelines, budgets, deliverables, and communications. 

How you’ll contribute: 

• Coordinate and drive clinical program development strategy and execution of activities within and across clinical programs 
• Identify and mitigate risks to timelines and quality issues, resolve issues around scope and cost change across clinical trials and programs 
• Identify and propose solutions for resource constraints 
• Interact with senior leadership and cross-functional representatives on strategic product development plans and other mission-critical actions ● Coordinate activities between Clinical Study Operations, Quality, Medical Affairs, Commercial Operations, R&D, Clinical Laboratory, Clinical Informatics, Engineering, Regulatory, etc. to ensure the timely and compliant execution of clinical trials across programs 
• Lead tactical execution of deliverables of all aspects of assigned clinical studies within a program, including, investigator selection, study startup, authoring/reviewing study-related documentation, study conduct, and closeout activities. 
• Lead analysis and preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team and provide recommendations to senior management on partner selection. 
• Independently manage Clinical Research Organizations (CROs) and other vendors, including contracts, budgets, and invoicing 
• Provide regular updates of program progression to upper management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related matters 
• Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports ● Lead study feasibility assessments and selection of countries and sites for study conduct 
• Assure compliance with all regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA, and applicable international regulations concerning clinical activities. 
• Lead implementation of data collection, clinical trial database construction, and assists with necessary audits of data to ensure data integrity. 

What You’ll Bring:

• BS/MS degree, at least eight years of clinical trial and program management experience, in vitro diagnostics (IVD) preferred 
• Clinical experience in oncology, either inpatient or outpatient 
• Experience independently developing clinical protocol; designing, planning, and managing clinical studies, study planning, and management 
• Expert and independent experience managing CROs and other vendors ● Knowledge of GCP, ICH, and US and International clinical regulatory guidelines ● Excellent independent problem solving skills, verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills 

• Experience with and ability to learn computer programs, i.e. G-Suite, MS Word, PowerPoint, Excel and Project, JIRA, Wrike, etc. 
• Ability to travel as required (~25%) 

COVID safety:

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.

Funding

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. 

Freenomers

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 

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)

• Equal Employment Opportunity (EEO)

• Employee Polygraph Protection Act (EPPA)

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.