Director Clinical Operations

We are seeking a Clinical Operations Lead to drive the planning, execution, and oversight of early‑phase oncology clinical trials within a fast‑paced, resource‑lean startup environment. This role is both strategic and hands‑on, driving study plans through to execution while managing CROs, vendors, timelines, and study quality. The ideal candidate brings deep oncology experience, demonstrates flexibility in a dynamic setting, and provides strategic direction while staying closely engaged in day‑to‑day study operations.

As one of the first clinical operations hires, this leader will shape operational processes, ensure inspection‑ready execution, and contribute directly to the success of first‑in‑human and early‑development programs.

• Lead and support the planning, initiation, execution, and close‑out of clinical trials (Phase I–III)
• Manage day‑to‑day clinical operations activities while ensuring timelines, quality, and budget adherence
• Coordinate cross‑functional teams (clinical monitoring, data management , biostatistics, regulatory, safety)
• Track enrollment, site performance, and operational KPIs
• Identify operational risk s and implement mitigation strategies
• Select, manage, and oversee CROs and vendors
• Review and approve monitoring reports, metrics, and deliverables
• Oversee deliverables, quality, timelines, and budget adherence
• Drive CROs to achieve project deliverables in alignment with internal project goals
• Ensure CRO teams are trained, aligned and performing to expectations
• Serve as the primary operational point of contact for external partners

• Ensure trials are conducted in compliance with ICH‑GCP, FDA, MHRA, EMA, and local regulations
• Support regulatory submissions and approvals in the US and Ex‑US (e.g., IND/CTA)
• Oversee Trial Master File (TMF) completeness and inspection readiness

• Support site selection, initiation, and ongoing site management
• Collaborate with investigators and site staff to address enrollment, compliance, and quality issues
• Identify and mitigate operational risks impacting site performance

• Support development and management of study budgets
• Track actuals vs. forecast, identify variances, and recommend corrective actions to maintain financial discipline.
• Participate in vendor budget negotiations and ensure cost assumptions are clear, justified, and aligned with study needs.

• Skilled in risk management, timeline forecasting, and operational problem‑solving.
• Ability to interpret data and make evidence‑based decisions.

• Work closely with Clinical Development, Regulatory Affairs, and Data and Safety Management
• Provide operational input into protocol design, feasibility, and study budget and timelines
• Contribute to process development and continuous improvement in a startup setting

• Bachelor’s degree in life sciences or related field (advanced degree preferred)
• 10+ years of hands‑on clinical operations experience (flexible based on seniority)
• Experience in execution of oncology clinical trials
• Direct experience managing clinical trials in the US and Ex‑US
• Strong knowledge of ICH‑GCP and global clinical trial regulations
• Proven ability to work independently and manage multiple priorities
• Experience working in a startup or small biotech environment

• Experience across multiple trial phases (Phase I–III)
• Prior involvement in inspections or audits (FDA, EMA, MHRA)
• Ability to build and improve clinical operations processes from the ground up Hands‑on, execution‑focused mindset
• Strong organizational and project management skills
• Excellent communication and presentation skills and stakeholder management abilities
• Proactive problem‑solver comfortable with ambiguity
• Team‑oriented with a strong sense of ownership

• Opportunity to make a direct impact on clinical programs and patients
• High visibility and responsibility in a growing startup