Vice President Clinical Operations

Slate Medicines; Raleigh (NC); On-site; USD 250,000 - 350,000; Full time

Job summary

Slate Medicines, a clinical-stage biotechnology company, seeks an experienced Vice President of Clinical Operations to lead end-to-end planning and execution of its clinical studies. This hands-on leadership role defines the operating model, selects external partners, and grows the internal Clinical Operations organization as the program advances.

The VP will own study timelines, budgets, risk mitigation, and vendor performance while partnering with Clinical Development, Regulatory,

Qualifications

• Sponsor-side Clinical Operations experience with leadership responsibilities.
• Experience managing Phase 2/3 studies from start-up to database lock.
• Knowledge of ICH GCP and regulatory requirements in the regions of study.
• Proven CRO selection, contracting, and oversight track record.
• Experience building Clinical Operations capabilities in a lean environment.
• Strong communication and stakeholder alignment across teams.

Responsibilities

• Own Clinical Operations planning and execution for development-stage studies, from start-up to delivery.
• Lead CRO strategy: evaluation, contracting, governance, and ongoing performance management.
• Build infrastructure, processes, and systems suitable for a lean clinical-stage company.
• Develop and manage study timelines, budgets, risk mitigation, and vendor performance.
• Partner with Clinical Development, Regulatory, Biostatistics/Data Management, and other stakeholders.
• Build the internal Clinical Operations team over time, including hiring priorities and responsibilities.
• Operate as a hands-on leader balancing strategy with program execution details.
• Provide clear, timely communication to executive leadership on status, risks, decisions, and resourcing.

Skills

Clinical Operations

Leadership

Vendor Management

GCP/ICH E6

Regulatory Knowledge

Cross-functional Collaboration

Job description

Slate Medicines is a clinical-stage biotechnology company committed to advancing innovative new therapies that may broaden the treatment paradigm and potentially improve outcomes for people with migraine and other headache disorders. Slate is advancing a portfolio of potentially best-in-class therapeutics, led by SLTE-1009, a clinical-stage anti-PACAP/VIP monoclonal antibody designed to enable subcutaneous, infrequent dosing.

The Role

Slate Medicines is seeking an experienced Clinical Operations leader to build and lead the function as the company advances its lead program through clinical development. This is a highly visible, hands-on leadership role with end-to-end responsibility for planning and executing Slate’s clinical studies. The Vice President, Clinical Operations will define the clinical operating model, select and lead external partners, build the infrastructure required for execution, and grow the internal Clinical Operations organization as the program expands. The role suits a senior operator who is energized by the opportunity to build, make decisions, and take broad ownership in a well-funded, fast-moving biotech environment.

Key Responsibilities

• Own Clinical Operations planning and execution for the company’s clinical studies, from development planning and study start-up through operational delivery.
• Lead CRO strategy - evaluation, selection, contracting, governance, and ongoing performance management.
• Build practical Clinical Operations infrastructure, processes, and systems appropriate for a lean clinical-stage biotechnology company.
• Develop and manage study timelines, budgets, operational plans, risk mitigation, and vendor performance.
• Partner closely with Clinical Development, CMC, Regulatory, Biostatistics/Data Management, and other internal and external stakeholders.
• Build the internal Clinical Operations team over time, including defining organizational needs, hiring priorities, and operating responsibilities.
• Operate as a hands-on leader who moves easily between strategic decision-making and staying close to program execution and the details that matter.
• Provide clear, timely communication to executive leadership on program status, risks, decisions, and resourcing needs.

Experience

• 10+ years in sponsor-side Clinical Operations, including direct ownership of at least one Phase 2 or Phase 3 study from start-up through database lock.
• Working knowledge of ICH E6 GCP and applicable regulations in the regions where our studies are run.
• Strong CRO selection, contracting and oversight track record, including managing a study that went off plan and bringing it back.
• Experience building Clinical Operations capabilities, teams, and infrastructure in an entrepreneurial environment.
• Comfort working in a lean organization where senior leaders are expected to be highly engaged in execution.
• Sound judgment, a strong sense of urgency, and excellent communication skills, with the ability to build alignment across internal teams and external partners.
• Experience in CNS, neurology, migraine, or pain is advantageous but not required. Specific modality experience is not required.