Remote Clinical Biomarker Lead
Location | New Jersey |
Discipline: | Medical & Pharmacovigilance |
Job type: | Permanent |
Salary: | £Excellent salary, bonus, benefits and stock |
Contact name: | Stuart Gilboy |
Contact email: | stuart.gilboy@rbwconsulting.com |
Contact phone: | 16179821238 |
Job ref: | 21633 |
Published: | almost 3 years ago |
Expiry date: | 26 Jul 2023 11:59 |
Location: New Jersey or Remote
Our client is a well-funded, innovative oncology biotech in New Jersey who 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 position reports directly to the Head of the Clinical Biomarkers and Diagnostics function. 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.
Job details
Innovate, 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.
Deliver translational analysis plans 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.
Be the Clinical Biomarker Lead for multiple phase clinical trials ranging phase I-II.
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
Collaborate with clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, lab manuals and consent forms
Deliver 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.
Collaborate and engage in high-performance 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.
Requirements
Extensive experience in the development of clinical biomarkers with a proven track record of success.
Five to eight years in biotechnology, pharmaceutical industry, or clinical setting in the application of biomarkers in clinical trials preferably in oncology biomarker development.
Ph.D. in a life scientific discipline
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.
Skilled and experienced 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.
For more information on this role and the pipeline of the company please forward your resume to stuart.gilboy@rbwconsulting.com
Excellent salary, bonus, benefits and stock
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