Our client is a rapidly growing pharmaceutical company developing novel hyperbolic inhibitors for cancer patients. As they expand their clinical team, they're seeking a seasoned Director of Clinical Operations to lead the strategic and operational oversight of their multicenter oncology trials. This is a unique opportunity to directly influence the development of brand-new therapies.

About the Role

As the Director of Clinical Operations, you will be responsible for the end-to-end operational leadership of our oncology trials. You’ll work cross-functionally to align execution with corporate goals, ensure Good Clinical Practice (GCP) compliance, and build a high-performing team dedicated to excellence in clinical development. This role requires strategic vision, a hands-on leadership approach, and the ability to drive operational efficiency in a complex, fast-paced environment.

The responsibilities of the Director of Clinical Operations include, but are not limited to:

Strategic Leadership & Clinical Trial Oversight

• Lead the global strategy and execution of Phase 1a/b multi-center oncology trials.
• Drive study design, planning, and implementation in alignment with company milestones.
• Present strategic updates to the executive team and external stakeholders.
• Act as a liaison between the Site IRBs and the Clinical team to resolve queries and concerns.

Operational Excellence & Quality

• Oversee clinical trial timelines, budgets, and quality deliverables for all ongoing trials.
• Contribute to protocol development and key regulatory documents, ensuring scientific and operational rigor.
• Implement and uphold best practices, SOPs, and clinical systems to drive consistency and efficiency.
• Ensure inspection readiness and compliance with FDA, ICH, GCP and global regulatory standards.
• Perform and oversee reconciliation of data with vendors as needed.
• Perform investigations of deviations and monitor Corrective Actions & Preventive Actions (CAPA).

Vendor & CRO Management

• Lead the selection, contracting, and oversight of CROs and vendors, ensuring accountability and performance.
• Oversee study start-up activities and coordinate cross-functional support for site activation.
• Manage and participate in study-related meetings, ensuring alignment and effective communication, including ensuring timely and quality document generation by Clinical CROs (e.g., communication plan, site monitoring plan).
• Review vendor outputs, conduct oversight visits, and address operational challenges as they arise.
• Track timelines, budgets, and performance metrics, escalating risks proactively.
• Lead study close-out efforts to ensure thorough and timely completion.

Team Development & Leadership

• Build and lead a high-performing clinical operations team that is ready to grow as the company’s clinical programs advance.
• Cultivate a culture of ownership, collaboration, and continuous learning.
• Provide coaching and mentorship, and support professional development across the team.
• Lead training initiatives on SOPs, GCPs, and operational systems.
• Contribute to strategic decisions and the development of clinical and regulatory documents.

Qualifications

• Bachelor’s degree in a life sciences or healthcare-related discipline with 15+ years of relevant experience with at least 5 years in oncology Phase 1 trials OR advanced degree (PhD, MD, PharmD, MS) in a life sciences or healthcare-related discipline with 10+ years of experience in clinical operations, including Phase 1 oncology trials.
• Proven success in leading cross-functional teams and managing clinical operations
• Demonstrated ability to understand end-to-end management of clinical trial conduct, clinical drug development, and clinical trial operations.
• Strong experience with CRO oversight, vendor management, and regulatory compliance.
• Proficiency in clinical trial systems (e.g., CTMS, EDC, eTMF) and project management tools.
• Excellent communication, leadership, and problem-solving skills.
• Ability to adapt to new responsibilities as the role requires and to work in a fast-paced environment.