Director Clinical Operations

About the role

The Director of Clinical Operations provides strategic leadership for global clinical trial delivery within a CRO environment. This senior position drives operational excellence, ensures compliance with ICH‑GCP and regulatory standards, and supports commercial growth through business development initiatives.

Key responsibilities

• Lead Clinical Operations across all regions, guaranteeing quality, compliance, and consistency.
• Oversee end‑to‑end project delivery in line with ICH‑GCP, SOPs, and client expectations.
• Monitor and improve monitoring practices, conduct gap analyses and implement CAPAs.
• Plan and allocate resources efficiently and support the Quality Management System.
• Develop proposals, lead bid defenses, and represent Clinical Operations in client engagements.
• Build and maintain strong client and partner relationships, acting as senior point of contact.
• Mentor the Clinical Operations Manager and teams, fostering a culture of continuous improvement.
• Contribute to company strategy, marketing materials, and represent the organization in internal and external forums.

Required profile

• Advanced degree in Life Sciences, Pharmacy, Medicine, Business or a related field.
• Minimum 10 + years of experience in clinical research, including leadership roles.
• Deep knowledge of ICH‑GCP, regulatory requirements and clinical trial processes.
• Proven track record in both Clinical Operations and Business Development.
• Strong leadership, communication and client‑management abilities.

Required skills

• ICH‑GCP compliance
• Regulatory requirements expertise
• Clinical trial management
• Quality Management System (QMS) implementation