Head of Clinical Operations (Sr. Director / Executive Director)

Borealis Biosciences,

5d•Hybrid

About The 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.

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.

Nice To Haves

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

Responsibilities

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.
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 Borealis maintains appropriate sponsor oversight and ownership of its clinical programs.
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.
Ensure vendor scopes of work, budgets, assumptions, timelines, deliverables, and responsibilities are clearly defined and aligned across providers.
Establish fit-for-purpose vendor governance and oversight processes.
Monitor vendor performance against agreed KPIs, timelines, quality expectations, and budgets.
Develop site identification, feasibility, selection, and activation strategies in partnership with CROs and internal stakeholders.
Develop patient recruitment and retention strategies appropriate to the disease, protocol, and patient population.
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.
Design the Clinical Operations organization required to support Borealis’ evolving clinical portfolio.
Develop a thoughtful resourcing strategy that balances internal capabilities, CRO support, consultants, and functional service providers.
Recruit, onboard, develop, and retain high-performing Clinical Operations professionals as organizational needs grow.
Coach and mentor team members to expand beyond their existing expertise without compromising on delivery.
Model Borealis’ values, knowing that Patients are our True North: Act with urgency, resilience and creativity to serve patients; Be open to new ideas, honest conversations and two-way transparency; Stay connected to team members and to science; being kind, humble, and taking risks together.