Biomarker & Bioanalytical Development Lead (Director / Senior Director)

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.   

At Borealis Biosciences, Patients are our True North.  Borealis was founded on the premise that a convergence of scientific and translational breakthroughs will enable RNA therapeutics to address some of the largest untreated kidney diseases and beyond.  Borealis builds on the success of Chinook Therapeutics, a kidney disease company with a research site in Vancouver that was acquired by Novartis in 2023 for up to $3.5 billion. The Borealis team retains Chinook's strong experience in kidney diseases, while also bringing deep expertise in RNA therapeutics, to create a company uniquely focused on RNA-based solutions to renal diseases. We are headquartered in Vancouver, BC, with state-of-the-art wet labs for molecular and cellular biology, in vivo pharmacology, chemistry, DMPK, bioinformatics and analytical capabilities.  

We are a creative and innovative team that strives for excellence in all we do and has fun along the way. Our core focus is on helping patients and advancing science. For more information on Borealis, visit borealisbio.com  or find us on LinkedIn.    

We seek applicants from all backgrounds to ensure we get the best, most innovative talent on our team. We are building a diverse and inclusive workforce – come and be a part of our growth! We strongly encourage candidates with less traditional backgrounds or those who may meet the qualifications in a different way to apply. 

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 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. 
  • Recruit, onboard, develop, and retain high-performing scientists as organizational needs grow. 
  • 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. 
• Model Borealis’ values, knowing that Patients are our True North: 
  • Act with urgency, resilience and creativity to serve patients;   
  • Be open to new ideas, honest conversations and two-way transparency;   
  • Stay connected to team members and to science; being kind, humble, and taking risks together. 

Location:  

This is an on-site position located in Vancouver, BC, Canada. Immigration support and relocation benefits are available.  

Education, Experience, and Skills: 

Required: 

• PhD in pharmacology, analytical chemistry, molecular biology, immunology, biochemistry, or a related discipline with 10+ years of relevant biotechnology or pharmaceutical industry experience; BS/MS with additional equivalent experience may be considered. 
• Deep hands-on expertise in bioanalytical and biomarker assay development, including ligand-binding assays, LC-MS/MS, and/or molecular (qPCR/RT-qPCR) methods. 
• Demonstrated experience with method validation and sample analysis in regulated environments (GLP, GCLP, and/or CLIA), and a strong working knowledge of ICH M10 and related bioanalytical guidance. 
• Proven success leading outsourced bioanalytical and biomarker work, including selection, method transfer, and scientific oversight of CROs and specialty laboratories. 
• Experience supporting programs through IND-enabling studies and into early clinical development, with contributions to IND/CTA submissions. 
• Demonstrated experience building, leading, coaching, and developing scientific teams combined with the willingness to personally execute critical scientific activities. 
• Strong data interpretation and scientific judgment, with the ability to make timely decisions in environments characterized by uncertainty, evolving scientific data, and changing priorities. 
• Proven ability to work effectively across DMPK, Toxicology, Pharmacology, Translational Medicine, Clinical Development, Clinical Operations, Regulatory, and Quality. 
• Excellent written and verbal communication skills, including presenting complex data to senior leadership and external partners. 

Preferred: 

• Bioanalytical experience with oligonucleotide therapeutics (siRNA, ASO) or other novel modalities, including hybridization-based and LC-MS approaches. 
• Experience establishing or significantly expanding a bioanalytical or biomarker function within an emerging biotechnology company. 
• Experience with kidney-relevant biomarkers and matrices (e.g., urine, urinary extracellular vesicles, kidney biopsy tissue). 
• Experience with ultrasensitive immunoassay, multiplex proteomics, or transcriptomic platforms for biomarker discovery and translation. 
• Strong publication record and external scientific network. 

Compensation: The annual salary range is $202,000 to $235,700.  

Borealis Bio offers competitive benefits including annual bonus program, equity program, paid time-off, paid parental leave and more. Canada-based employees receive RRSP matching, extended medical, dental and vision and a Wellness Spending Account up to $1,800 per year. Actual base salary and title/level will be determined based on the qualifications of the successful candidate. 

Borealis is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.