epartment:
Director of Clinical Operations Consultant for a 6 month contract (potentially longer)
The Director, Clinical Operations is responsible for the planning and execution of global late-stage clinical trials, with a focus on quality, timelines, budget, vendor performance, and inspection readiness. This individual will combine hands-on operational leadership with strategic contribution to companies clinical development plans while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement. Must have experience with:
Global Trials (must have)
Large Phase 3 Trials (must have)
Oncology (must have)
Key Responsibilities
- Lead the planning, start-up, execution, and close-out of global late-stage clinical trials, proactively managing timelines, resources, budgets, risks, and quality.
- Provide operational leadership and contribute to late-stage Clinical Operations strategy, including integrated development plans and study protocols.
- Select and oversee CROs, vendors, and investigative sites; support contract and budget negotiations and use performance indicators to drive delivery and accountability.
- Ensure studies are conducted in compliance with Company SOPs, ICH-GCP, FDA requirements, EU CTR, other applicable regulations, and patient safety standards; maintain inspection readiness.
- Partner cross-functionally with Biometrics, Regulatory, Safety, Medical, and other functions to deliver high-quality study data, database locks, clinical study reports, and regulatory submissions.
- Build effective relationships with investigators, external experts, and partners; communicate issues and risks proactively and drive timely resolution.
- Support operational portions of protocols and investigator materials, regulatory authority interactions, and NDA/MAA registration activities; maintain awareness of evolving regulatory and competitive practices.
Skills and Qualifications
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline; advanced degree preferred.
- Minimum 5 years of progressive Clinical Operations experience, including leadership of pivotal Phase II and/or Phase III trials; oncology experience required, with multiple myeloma experience preferred.
- Demonstrated experience across the clinical trial lifecycle, including study planning/start-up, execution, vendor oversight, data cleaning, database lock, clinical study reporting, and inspection readiness.
- Strong knowledge of ICH-GCP, FDA regulations, EU CTR requirements, and global drug development; NDA/MAA filing or registration experience strongly preferred.
- Proven ability to manage complex projects, CROs and vendors, budgets, timelines, risks, and competing priorities in a fast-paced biotech environment.
- Results-oriented, proactive, and collaborative leader with strong judgment, problem-solving, communication, and influencing skills; able to balance hands-on execution with strategic direction.
Working Behaviors (Core Expectations)
- Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
- Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
- Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
- Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
Team Balance and Enablement: Contribute to balanced roles within the team, support delegation