Head of Clinical Operations – Sr. Director / Executive Director

Borealis Biosciences, Inc.

. Lead operational planning and execution of Borealis’ clinical development programs from early development through later-stage studies .

Posted 10/2/2026full-timeVancouver • CanadaSenior💰 $220,000 - $273,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive leadership in Clinical Operations, with a focus on planning and executing clinical trials, vendor management, and regulatory compliance. Proven ability to build and mentor teams while ensuring studies are delivered on time and within budget.

Highest-signal resume keywords

Clinical Operations LeadershipCRO Selection And ManagementPhase 1/2 Clinical Trial ExecutionICH-GCP ComplianceBudgeting And Resource Planning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial PlanningOperational Risk MitigationSOP DevelopmentVendor GovernanceEnrollment Strategy DevelopmentContract ManagementPerformance ManagementRegulatory Submission SupportFinancial AcumenStudy Budgeting

Soft Skills

LeadershipCommunicationNegotiationStakeholder ManagementDecision-Making

Industry Keywords

BiotechnologyPharmaceutical DevelopmentINDsCTAsClinical OperationsRare DiseaseKidney DiseaseRNA TherapeuticsFirst-In-Human StudiesClinical Development

About the role

Key responsibilities & impact

Lead operational planning and execution of Borealis’ clinical development programs from early development through later-stage studies
Lead end-to-end operational planning and execution of the upcoming Phase 1/2 clinical trial
Translate clinical development plans and protocols into operational strategies, timelines, budgets, enrollment projections, and risk mitigation plans
Establish study governance, decision-making processes, and accountability across internal and external study teams
Deliver studies on time and on budget in accordance with protocols, regulatory requirements, GCP, and Borealis quality standards
Identify operational risks and lead mitigation and contingency planning
Partner with Clinical Development, Regulatory, CMC, Data Management, Biostatistics, Translational Medicine, Quality, and other functions
Own outsourcing strategy and lead CRO identification, competitive selection, RFPs, bid defenses, proposal assessment, contracting, governance, and performance oversight
Establish and manage CRO and vendor expectations, responsibilities, escalation pathways, KPIs, timelines, quality standards, budgets, and deliverables
Define vendor strategy for central laboratories, imaging providers, IRT, eCOA, clinical supply/logistics providers, specialty laboratories, and other study service providers
Develop site identification, feasibility, selection, activation, patient recruitment, and retention strategies
Monitor enrollment performance and develop mitigation plans
Build investigator and site relationships and incorporate site needs into study planning and execution
Design the Clinical Operations organization and develop resourcing strategies
Recruit, onboard, develop, retain, coach, and mentor Clinical Operations professionals
Report to the Senior Vice President, Translational Medicine

Requirements

What you’ll need

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
Preferred: Experience establishing or significantly expanding a Clinical Operations function within an emerging biotechnology company
Preferred: Experience taking a program from preclinical development through first-in-human clinical execution
Preferred: Experience with Phase 1/2 studies involving complex protocols, specialty patient populations, or specialized vendors
Preferred: Deep experience in kidney disease, rare disease, or related therapeutic areas
Preferred: Experience with RNA therapeutics or other novel therapeutic modalities

Benefits

Comp & perks

Annual bonus program
Equity program
Paid time-off
Paid parental leave
Canada-based employees: RRSP matching
Canada-based employees: Extended medical, dental and vision
Canada-based employees: Wellness Spending Account up to $1,800 per year
US-based employees: 401(k) with company matching
US-based employees: Medical, dental and vision insurance
Immigration support
Relocation benefits