AI Summary

Lead planning and execution of biomarker strategy and assay development for preclinical and clinical oncology studies using gene therapy, collaborating with cross-functional teams and external partners.

About this role

You will lead the planning and execution of biomarker strategy and drive biomarker assay development for preclinical and clinical oncology studies using gene therapy modality. In this role, you will collaborate with cross-functional teams and external partners to drive clinical biomarker innovation for cancer gene therapy programs. This is an ideal position for a highly motivated individual who has strong wet-lab and data analysis skills, and thrives in a cross-disciplinary and collaborative environment.

Primary Responsibilities

Establish translatable biomarkers for preclinical and clinical development, including biomarkers for patient selection, drug response monitoring, pharmacodynamics and mechanism of action.

Design and validate biomarker assays, developing SOPs for robust and reproducible biomarker quantification using patient-derived specimens. Contribute to biomarker strategy in clinical trials.

Work closely with the biospecimen team to optimize, standardize and document pre-analytical biospecimen handling and processing conditions to support the transition of biomarker assays into clinical trials.

Oversee and manage relationships with CROs and vendors for outsourced clinical biomarker assay development, validation, and regulatory compliance.

Analyze biomarker data to derive insights into patient response, pharmacodynamics, and mechanisms of action.

Collaborate with regulatory teams to ensure biomarker strategies align with clinical trial and regulatory submission requirements.

Required Skills & Qualifications

PhD and/or MD with 3+ years of industry experience in oncology disease or cell/gene therapy (CGT).

Excellent understanding of drug development and regulatory processes.

Extensive hands-on experience developing biomarker assay protocols and analyzing patient specimens using techniques such as IHC/IF, ISH, ELISA and ELISPOT.

Experience leading biomarker assay outsourcing with external vendors/CROs.

Excellent written and communication skills.

Thrives in a fast-paced, high-growth environment with a track record of delivering results

on time and within budget

Proven ability to work independently and collaboratively in a team environment.

Skills

Biomarker Assay DevelopmentBiospecimen HandlingClinical Biomarker StrategyCRO/vendor ManagementData AnalysisDrug DevelopmentELISAELISPOTIHC/IFISHMechanism Of ActionPatient-derived SpecimensPharmacodynamicsRegulatory ComplianceRegulatory SubmissionsSOP Development

Biomarker Scientist, Immuno-oncology

About this role

Primary Responsibilities

Required Skills & Qualifications

Skills

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