Company:

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. Despite recent advances for certain kidney disease patients, many forms of highly prevalent kidney diseases do not have effective treatments.

Position:

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.





This position reports to the Sr. Vice President, Translational Medicine.

Responsibilities include:

- 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.

- Biomarker Strategy and Translational Science

- Lead development and qualification of assays to measure target knockdown and downstream pathway modulation in accessible matrices (e.g., plasma, urine,



urinary extracellular vesicles, kidney biopsy tissue).
- Evaluate and implement emerging biomarker technologies (e.g., ultrasensitive immunoassay, multiplex proteomics, targeted transcriptomics, spatial and single-cell approaches) where they strengthen program decision-making.
- Contribute biomarker expertise to clinical protocol design, sampling schedules, lab manuals, and sample handling and logistics plans.

- CRO and Specialty Laboratory Selection and Oversight

- 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 transparent 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 & Bioanalytica

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