Managing medical and emergency response operations at a remote industrial site for International SOS. Leading teams, client delivery, compliance, quality, equipment, and emergency preparedness.
BI
Head of Clinical Operations – Sr. Director / Executive Director
Posted yesterday
About the role
- Clinical Operations leader advancing Borealis’ RNA therapeutics for kidney disease into Phase 1/2 trials. Building teams, CRO partnerships, vendors, and trial infrastructure.
Responsibilities
- 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
- 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
- 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
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