Chronic kidney diseases are a severe and growing worldwide health challenge that affects 1 in 7 people. Without effective treatments patients can experience kidney failure leading to dialysis and transplantation, a high burden to patients, families and the health care system. The Biomarker & Bioanalytical Development Lead is Borealis' senior scientific owner of bioanalytical and biomarker strategy across our RNA therapeutics portfolio. This leader will design, build, and oversee the assays that measure drug exposure, target engagement, pharmacodynamic response, and safety in support of IND-enabling nonclinical and early clinical development. This is a highly visible, hands-on scientific leadership role with the opportunity to shape how Borealis generates the translational data that drives program decisions. The immediate focus for this role is preparing Borealis for its upcoming Phase 1/2 trial, including development, transfer, and validation of regulated PK assays for oligonucleotide therapeutics, selection, contracting, and scientific oversight of bioanalytical CROs and specialty laboratories, delivery of a fit-for-purpose clinical biomarker strategy that demonstrates target engagement in the kidney, and ensuring assay robustness and GxP compliance Over time, the successful candidate will build and develop the Biomarker & Bioanalytical team, thoughtfully balancing in-house laboratory capability with external partnerships, which requires a genuine commitment to mentoring and the patience to support team members stretching beyond their current specialization. We are building a diverse and inclusive workforce – come and be a part of our growth Bioanalytical Strategy and Assay Development Define and own the bioanalytical strategy for Borealis' RNA therapeutic programs,



from discovery through IND-enabling studies and clinical development. Lead development of fit-for-purpose assays to quantify oligonucleotide therapeutics and relevant metabolites in plasma, urine, and tissues (e.g., hybridization ELISA, LC-MS/MS, LC-HRMS, stem-loop RT-qPCR) to support PK, tissue distribution, and exposure–response analyses. Establish immunogenicity (ADA) strategy and assays where required by modality, conjugate, or regulatory expectations. Ensure method validation and sample analysis meet applicable regulatory expectations (ICH M10, FDA/Health Canada/EMA guidance, GLP, and GCLP). Partner closely with DMPK, Toxicology, Pharmacology, and Chemistry to integrate bioanalytical data into PK/PD modeling, dose selection, and program decisions. Investigate and resolve assay performance issues, and drive continuous improvement of assay robustness, sensitivity, and throughput. Lead development and qualification of assays to measure target knockdown and downstream pathway modulation in accessible matrices (e.g., Own the outsourcing strategy for bioanalytical and biomarker work supporting GLP toxicology studies and upcoming Phase 1/2 clinical trials. Lead identification, qualification, and selection of bioanalytical CROs, central and specialty laboratories, including scope definition, proposal assessment, and budget review in partnership with Finance and Legal.



Lead method transfer from Borealis laboratories to external partners, and provide scientific oversight of method validation, sample analysis, and data reporting. Review and approve validation plans and reports, sample analysis reports, and data packages; ensure data integrity and audit readiness. Set clear expectations, timelines, KPIs, and escalation pathways, and actively monitor partner performance and quality. Regulatory and Cross-Functional Contributions Communicate data, interpretations, and recommendations clearly to project teams, senior leadership, and external partners. Partner with Clinical Operations, Clinical Development, Quality, Data Management, and Biostatistics to ensure seamless sample and data flow across studies. Team Building and Leadership Design the Biomarker & Bioanalytical organization required to support Borealis' evolving portfolio, balancing in-house laboratory capability with CROs, consultants, and academic collaborators. Build and maintain in-house laboratory capabilities, including equipment, SOPs, documentation practices, and quality systems appropriate to an early-stage company. Coach and mentor team members to expand beyond their existing expertise without compromising on scientific rigor or delivery. Build a culture of ownership, collaboration, transparency, scientific rigor, continuous improvement, and thoughtful urgency. Act with urgency, resilience and creativity to serve patients; being kind, humble, and taking risks together. This is an in office position located in Vancouver, BC, Canada. Immigration support and relocation benefits are available. PhD in pharmacology, analytical chemistry, molecular biology, immunology, biochemistry, or a related discipline with 10+ years of relevant biotechnol

📌 Biomarker & Bioanalytical Development Lead (Director / Senior Director) (Vancouver)
🏢 Borealis Biosciences
📍 Vancouver