Head of Clinical Operations

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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 Head of Clinical Operations leads the operational planning and execution of Borealis’ clinical development programs and builds the company’s clinical operational capability as our first programs advance into human studies. This is a highly visible, hands‑on leadership role with the opportunity to build the people, processes, systems, and external partnerships required to successfully execute Borealis’ clinical development strategy.

The near‑term priority for this role is operational planning for Borealis’ upcoming Phase 1/2 trial, including CRO selection and contracting, vendor strategy, study start‑up planning, and establishment of the operational infrastructure required for trial execution.

The successful candidate will build and develop the Clinical Operations team over time, which calls for a genuine interest in 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:

Clinical Operations

Provide strategic and operational leadership for Borealis’ clinical development programs from early development through later‑stage studies as the portfolio advances.

Lead end‑to‑end operational planning and execution of clinical trials, with an initial focus on the company’s upcoming Phase 1/2 study.

Translate clinical development plans and protocols into executable operational strategies, timelines, budgets, enrollment projections, and risk mitigation plans.

Establish study governance, decision‑making processes, and clear accountability across internal and external study teams.

Deliver studies on time and on budget, in accordance with protocols, applicable regulatory requirements, GCP, and Borealis quality standards.

Identify operational risks early and lead mitigation and contingency planning.

Partner closely with Clinical Development, Regulatory, CMC, Data Management, Biostatistics, Translational Medicine, Quality, and other functions to support integrated clinical development planning.

CRO Selection, Contracting and Oversight

Own the outsourcing strategy for upcoming Phase 1/2 clinical trials and future clinical programs.

Lead the CRO identification and competitive selection process, including development of RFPs, evaluation criteria, bid‑defense strategy, proposal assessment, and final CRO recommendation.

Partner with Finance, Legal, and other stakeholders to establish study scope, budgets, assumptions, contracts, and change‑order management processes.

Set clear expectations, roles, responsibilities, escalation pathways, and performance standards for CRO partners.

Actively oversee CRO performance throughout study execution and establish operational and executive‑level governance structures.

Build productive, accountable relationships with CRO partners while ensuring Boreal