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. 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. 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 cutting-edge 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. We are building a diverse and inclusive workforce – come and be a part of our growth! 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.

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. Vice President, Translational Medicine. 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. 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. Own the outsourcing strategy for upcoming Phase 1/2 clinical trials and future clinical programs.

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.

Define vendor strategy required to support each clinical program, including central laboratories, imaging providers, IRT, eCOA, clinical supply/logistics providers, specialty laboratories, and other service providers as required by study design. Lead vendor identification, qualification, selection, contracting, and implementation. Monitor vendor performance against agreed KPIs, timelines, quality expectations, and budgets.

Site Start‑Up, Enrollment and Study Delivery Develop site identification, feasibility, selection, and activation strategies in partnership with CROs and internal stakeholders. Monitor enrollment performance and lead development of mitigation. Build strong investigators and sites relationships, and ensure that site needs and operational realities inform study planning and execution.

Team Building and Leadership Act with urgency, resilience and creativity to serve patients; being kind, humble, and taking risks together. This is a hybrid/remote position open to candidates in the US or Canada, with a preference given to those in the Greater Vancouver area or willing to relocate. Immigration support and relocation benefits are available.

Regular travel to the Vancouver office is required.

Significant Clinical

Operations leadership experience in biotechnology or pharmaceutical development, including experience working within lean, fast‑moving organizations. Proven success leading outsourced clinical trials with effective sponsor oversight of CROs and other external partners.



Direct experience leading CRO selection and outsourcing activities, including RFP development, bid defenses, proposal and budget evaluation, contracting, governance, and performance management.

Strong experience planning and executing early‑stage clinical trials, preferably including first‑in‑human and Phase 1/2 studies. Demonstrated ability to build Clinical Operations capabilities, including development and implementation of SOPs, processes, tools, systems, and governance structures.

Experience selecting, managing, and overseeing multiple clinical trial vendors and establishing effective vendor governance and performance management. Demonstrated experience building, leading, coaching, and developing Clinical Operations teams. Ability and willingness to operate as a hands‑on leader who can personally execute critical activities while building an organization for future growth.

Experience supporting global clinical trial execution and clinical operational activities associated with INDs, CTAs, and other regulatory submissions. Strong understanding of ICH‑GCP, sponsor oversight responsibilities, clinical trial quality, and inspection readiness. Strong financial and operational acumen, including study budgeting, forecasting, contract management, change‑order management, and resource planning.

Proven ability to work effectively across Clinical Development, Regulatory, CMC, Quality, Data Management, Biostatistics, Finance, Legal, and other functions. Strong judgment and ability to make timely decisions in environments characterized by uncertainty, evolving scientific data, and changing priorities. Excellent communication, negotiation, leadership, and stakeholder‑management skills.

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. US‑based employees receive 401(k) with company matching, medical, dental and vision insurance.

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. #

📌 Head of Clinical Operations (Sr. Director / Executive Director) (Vancouver)
🏢 Borealis Biosciences
📍 Vancouver