Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists. Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.
We are seeking a Clinical Biomarker Lead that will be accountable for delivery of robust, scientifically driven biomarkers in drug development programs for synthetic lethal drug targets in oncology. This individual will have the opportunity to impact an industry-leading portfolio of Synthetic Lethal Drug Programs from inception of drug candidate and throughout clinical development.
- Identify, develop and implement cutting edge science and technological advances into biomarker and companion diagnostic (CDx) strategies to guide indication selection, patient enrichment, and combination strategies.
- Develop translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives. Measure target engagement reliably and quantifiably to inform clinical decisions for selecting therapeutically relevant doses and schedules.
- Understand key cancer pathway interactions and feedback mechanisms in clinical samples to guide rational drug combinations.
- Define novel mechanisms of resistance targeted therapies by studying tumors at relapse
- Provide input to clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, lab manuals and consent forms
- Provide scientific expertise and technical guidance to enable timely biomarker sample collection.
- Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy. Point contact for resolving study biomarker issues.
- Manage effective working relationships with clinical operations, clinical science, biology leads, bioinformatics and regulatory functions.
- Establish and manage external collaborations with leading academic groups, diagnostic partners, and CROs.
- Contribute to scientific credibility of company through contributions to the scientific literature (publications/presentations).
- Ph.D. in a life scientific discipline
- 3-5 years in biotechnology, pharmaceutical industry or clinical setting in the application of biomarkers in clinical trials preferably in oncology biomarker development.
- Extensive experience in the development of clinical biomarkers with a proven track record of success.
- Highly experienced in oncology translational research on molecularly targeted therapies, with proven track record of high-impact contributions to biomarker discovery and/or assay development.
- Experience in conducting clinical trials, conducting biomarker analyses on various clinical sample types and working as part of a clinical study team.
- Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms.
- Experience with developing and validating fit for purpose clinical assays
- Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment.
- Strong interpersonal skills and ability to thrive in a matrix environment.
- Experience in managing research collaborations, contract laboratories and budgets.
- Dependable and trustworthy, willing to take ownership and responsibility.