Biomarker & Bioanalytical Strategy Lead, RNA Therapeutics

Borealis Biosciences, Inc.; Vancouver; In loco; CAD 288.000 - 336.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Equity program

RRSP matching

Paid time-off

Descrizione del lavoro

Borealis Biosciences, Inc. is seeking a Biomarker & Bioanalytical Development Lead to own the bioanalytical and biomarker strategy across the RNA therapeutics portfolio.

This senior scientist will design, build, and oversee assays measuring drug exposure, target engagement, pharmacodynamic response, and safety to support IND-enabling nonclinical and early clinical development. The role focuses on preparing for a Phase 1/2 trial, including development and transfer of regulated PK assays,

Competenze

• PhD in pharmacology, analytical chemistry, molecular biology, immunology, biochemistry, or related discipline with 10+ years of relevant biotech/pharma experience.
• BS/MS with additional equivalent experience may be considered.
• Deep hands-on expertise in bioanalytical and biomarker assay development.
• Experience in regulated environments (GLP, GCLP, CLIA) and ICH M10 guidance.
• Proven success leading outsourced bioanalytical and biomarker work, including CRO selection and method transfer.
• Strong data interpretation and scientific judgment; cross-functional collaboration.

Mansioni

• Define and own the bioanalytical strategy for Borealis RNA programs from discovery through IND-enabling studies.
• Lead development of fit-for-purpose assays to quantify oligonucleotide therapeutics and metabolites in plasma, urine, and tissues.
• Establish ADA strategy and assays where required by modality or regulatory expectations.
• Ensure method validation and sample analysis meet regulatory expectations (ICH M10, GLP/GCLP/CLIA).
• Partner with DMPK, Toxicology, Pharmacology, and Chemistry to integrate bioanalytical data into PK/PD modeling and program decisions.
• Lead CRO/biomarker outsourcing, including selection, transfer, and oversight of labs and reports.
• Build and mentor the Biomarker & Bioanalytical team; foster ownership and scientific rigor.
• Promote Borealis values and a culture of collaboration, transparency, and urgency.

Conoscenze

Bioanalytical assays

Biomarker assays

GLP/GCLP/CLIA

CRO management

IND submissions

Leadership

Cross-functional

Formazione

PhD or equivalent

BS/MS + equivalent experience

Strumenti

LC-MS/MS

LC-HRMS

Stem-loop RT-qPCR

Hybridization ELISA

Descrizione del lavoro

Borealis Biosciences, Inc. is seeking a Biomarker & Bioanalytical Development Lead to own the bioanalytical and biomarker strategy across the RNA therapeutics portfolio.

This senior scientist will design, build, and oversee assays measuring drug exposure, target engagement, pharmacodynamic response, and safety to support IND-enabling nonclinical and early clinical development. The role focuses on preparing for a Phase 1/2 trial, including development and transfer of regulated PK assays,