Director, Clinical Sciences
About the Role
In this newly-created Director, Clinical Sciences role, you will contribute to the clinical study design, quality implementation, analysis, interpretation, and regulatory report writing as part of Freenome's product and platform development efforts. You will provide expertise and establish clinical and scientific strategies and tactics to obtain, analyze, and report the trial data to the regulatory authorities.
How you'll contribute:
As one of the leaders and key members of the clinical development team, you will contribute to the successful implementation of the clinical trials that lead to product registration and commercialization. The position embodies the following focus and responsibilities.
- The senior-level clinical scientist serves as the expert in our cross-functional team to ensure the design integrity and execution success of the clinical trial programs to obtain the regulatory submission needed clinical data
- Take on the leadership role in the authoring and development of clinical trial protocol, data capture instruments (such as CRFs), and related study documentation
- Work with KOLs and Principal Investigators in the accurate interpretation of the protocol and assist the clinical operations team in the timely execution of the clinical trials with the highest possible quality standards
- Work with biometrics (data management and biostatistics) to acquire the clinical data and generate the analyses to gain clinical evidence in support of the product development objectives
- Organize and perform the study level and individual subject level analysis of the clinical trial data to gain insights and develop strategies for the clinical study report (CSR) writing
- Responsible for the preparation of the clinical materials for the regulatory submissions of the assigned clinical product including the medical literature review, epidemiology analysis, IFU, and SSED, etc.
- Assist in the establishment of clinical trial quality execution processes, SOPs and instructions/lab manuals, QSR compliant and data analysis software tools
What you'll bring:
- MD or Ph.D. in a biological or related scientific field with prior experience in clinical research; A Master's degree may be considered with strong industrial experience
- Minimum of 8 years of clinical development experience with large scale oncology trial experience preferred
- Extensive knowledge and experience in acquiring biospecimen and histopathology based clinical data and conducting relevant exploratory analyses
- Excellent working knowledge of ICH GCP guidelines, CFR, and HIPAA regulations
- Thorough understanding of the clinical development and regulatory registration requirements for IVD products
- Demonstrated capability in bridging the communication of functional areas of diagnostic product development
- Effective and influential communication skills to represent the clinical development team and present the clinical study results to senior management and external stakeholders
- Strong interpersonal skills to enable collaborative relationships internally and externally
Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer.
We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw. By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science.
Our recent $270 Million Series C brings our financing to over $500 million from investors, including; Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society's BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences.
Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure.
By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome's datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.
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.
We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve. We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives. We believe in empowering and supporting each other in a collaborative and dynamic environment.
What does a successful person look like at Freenome?
Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others' good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there's no better place to be than Freenome.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.