​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