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Borealis Biosciences, Inc.
Borealis Biosciences, Inc.
11 – 50 Angajați
Asistență medicalăBiotehnologieProduse farmaceutice
Borealis Biosciences, Inc. este o companie de biotehnologie care dezvoltă terapii ARN țintite pentru boli renale. Bazându-se pe expertiza științifică și translațională de la Chinook Therapeutics, echipa sa reunește competențe în livrarea ARN, biologie sistemică, chimie medicinală, DMPK și farmacologie pentru a dezvolta tratamente pentru boala cronică de rinichi și afecțiuni asociate. Compania se concentrează pe ținte validate ale bolii, care pot fi dificil de abordat cu medicamente convenționale bazate pe molecule mici sau cu produse biologice.
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Locurile de muncă ale companiei

Head of Clinical Operations, Senior Director / Executive Director

Lead clinical operations for Borealis Biosciences’ RNA therapeutics programs in kidney disease, including upcoming Phase 1/2 trials. Build teams, oversee CROs and vendors, and establish the infrastructure needed for successful clinical execution.

CACanada
220.000 $ – 273.000 $ / an
HibridNormă întreagăSeniorLimbă Obligatorie: englezăOperațiuni clinice
Google Cloud Platform

Descriere

  • Direct operational planning and execution for Borealis’ clinical development programs from early development through later-stage studies
  • Lead end-to-end planning and execution for the upcoming Phase 1/2 clinical trial
  • Convert development plans and protocols into operational strategies, timelines, budgets, enrollment forecasts, and risk controls
  • Set study governance, decision-making frameworks, and accountability across internal and external teams
  • Deliver trials on schedule and within budget while meeting protocol, regulatory, GCP, and company quality requirements
  • Assess operational risks and lead mitigation and contingency planning
  • Collaborate with Clinical Development, Regulatory, CMC, Data Management, Biostatistics, Translational Medicine, Quality, and related functions
  • Own the outsourcing strategy, including CRO sourcing, competitive selection, RFPs, bid defenses, proposal reviews, contracting, governance, and performance oversight
  • Define and manage CRO and vendor expectations, accountabilities, escalation routes, KPIs, timelines, quality standards, budgets, and deliverables
  • Set vendor strategies for central laboratories, imaging, IRT, eCOA, clinical supply and logistics, specialty laboratories, and other study providers
  • Develop strategies for site identification, feasibility, selection, activation, patient recruitment, and retention
  • Track enrollment results and implement corrective action plans
  • Develop investigator and site partnerships and incorporate site requirements into study planning and delivery
  • Shape the Clinical Operations organization and establish resourcing plans
  • Recruit, onboard, develop, retain, coach, and mentor Clinical Operations staff
  • Report to the Senior Vice President of Translational Medicine

Cerințe

  • Extensive Clinical Operations leadership experience in biotechnology or pharmaceutical development, ideally within lean and rapidly evolving organizations
  • Demonstrated success managing outsourced clinical trials and providing effective sponsor oversight of CROs and external partners
  • Hands-on experience with CRO selection and outsourcing, including RFPs, bid defenses, proposal and budget reviews, contracting, governance, and performance management
  • Substantial experience planning and delivering early-stage trials, preferably first-in-human and Phase 1/2 studies
  • Track record of building Clinical Operations capabilities through SOPs, processes, tools, systems, and governance frameworks
  • Experience selecting, managing, and overseeing multiple clinical trial vendors with structured governance and performance controls
  • Experience building, leading, coaching, and developing Clinical Operations teams
  • Willingness to serve as a hands-on leader while establishing an organization designed for future growth
  • Experience supporting global trial execution and operational activities related to INDs, CTAs, and other regulatory submissions
  • Thorough knowledge of ICH-GCP, sponsor oversight duties, clinical trial quality, and inspection readiness
  • Strong financial and operational expertise covering study budgets, forecasts, contracts, change orders, and resource planning
  • Ability to work effectively across Clinical Development, Regulatory, CMC, Quality, Data Management, Biostatistics, Finance, Legal, and other functions
  • Sound judgment and timely decision-making in settings shaped by uncertainty, evolving data, and shifting priorities
  • Outstanding communication, negotiation, leadership, and stakeholder-management abilities
  • Preferred: Experience creating or substantially scaling a Clinical Operations function at an emerging biotechnology company
  • Preferred: Experience advancing a program from preclinical development through first-in-human execution
  • Preferred: Experience with Phase 1/2 trials involving complex protocols, specialized patient populations, or specialized vendors
  • Preferred: Extensive knowledge of kidney disease, rare disease, or related therapeutic areas
  • Preferred: Experience with RNA therapeutics or other novel treatment modalities

Beneficii

  • Annual bonus opportunity
  • Equity participation program
  • Paid time off
  • Paid parental leave
  • RRSP matching for Canada-based employees
  • Extended medical, dental, and vision coverage for Canada-based employees
  • Wellness Spending Account of up to $1,800 annually for Canada-based employees
  • 401(k) with company matching for US-based employees
  • Medical, dental, and vision insurance for US-based employees
  • Immigration assistance
  • Relocation support

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