Senior Director, Clinical Operations

Required

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• At least 10 years of progressive clinical operations experience within biotechnology, pharmaceutical, or CRO organizations, including leadership responsibility for early-stage clinical programs.
• Demonstrated success leading the operational execution of both clinical pharmacology studies (first-in-human, SAD/MAD, PK/PD, drug-drug interaction, food effect) and Phase I/II patient studies, including global and multi-center trials, with a clear emphasis on early development.
• Significant experience overseeing CROs and external vendors, including governance, performance management, quality oversight, and budget accountability.
• Strong understanding of clinical development strategy and the operational considerations associated with early-stage drug development.
• Hands-on experience with global operational strategy: country and site selection, feasibility assessment, enrollment modeling, and scenario planning to support program-level decision-making.
• Proven ability to lead multiple concurrent clinical programs while effectively balancing competing priorities in a fast-paced environment.
• Deep knowledge of ICH-GCP, FDA, EMA, and other applicable regulatory requirements governing clinical research.
• Experience managing clinical trial budgets, resource planning, forecasting, and operational risk management.
• Demonstrated success building collaborative relationships across Clinical Development, Biometrics, Regulatory, Quality, and executive leadership.
• Excellent leadership, communication, and negotiation skills, with proven ability to influence and align senior stakeholders, including portfolio company executives, CMOs, investigators, and CRO partners, without direct authority.
• Track record of introducing new technologies, tools, or ways of working within clinical operations, and of leading the change management required for adoption.