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Pattern Biosciences · 4 months ago

Biomarker Scientist, Cancer Gene Therapy

South San Francisco

Full-time

Onsite

Mid, Senior Level

3+ years exp

Pattern Biosciences is a company focused on designing biological circuits for targeted cancer therapies. They are seeking a Biomarker Scientist to lead biomarker strategy and assay development for oncology studies, collaborating with teams to drive clinical biomarker innovation.

BiotechnologyGeneticsHealth CareTherapeutics

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

Qualification

Biomarker assay developmentOncology experienceData analysisDrug development processesRegulatory complianceIHC/IF techniquesELISA techniquesCommunicationTeam collaborationIndependent work

Required

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