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.
Freenome’s Director of Clinical Excellence Contractor 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.
- As a member of the Clinical Quality Operations Excellence team, you will provide leadership and GCP subject matter expertise within R&D Quality & Medical Governance, and key functional development leaders
- Serve as the Clinical Quality Business Partner lead for Clinical Operations and Clinical Development
- Key partner for internal R&D, Regulatory, Quality & Medical Affairs by representing Clinical Development
- Provide guidance to functions on procedural development and review to assure alignment with internal processes and regulatory requirements
- 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
- Provide timely risk-based compliance advice that facilitates decision making
- Partner/advise functional area in the development & investigation of internal deviations or CAPAs
- 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.
- Support relevant functional areas in preparation for regulatory agency inspections
- Supervise, develop, train and manage internal staff as appropriate
- Lead clinical quality forums and assure management visibility of quality performance across function groups
Your background, perspective and experience:
- BS/MS degree in a scientific discipline, with at least 12 years, or a Ph.D., with >8 years of clinical research and quality management experience
- Significant experience working to or advising business on GCP regulations and ICH E6 R2 guidance, in vitro diagnostics (IVD) preferred
- Must have experience advising business in a compliance related role/ auditing experience, including vendor qualification and management
- Recognized as an expert resource on a range of clinical compliance topics and clinical trial process design and improvement
- 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, etc.
- Ability to travel as required (~15%)
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.
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Applicants have rights under Federal Employment Laws.
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