Head of Clinical Operations

About the role

The Head of Clinical Operations is a strategic leader responsible for directing all clinical trial activities across the organization. This role ensures that clinical programs are executed efficiently, comply with regulatory standards, and align with the company’s therapeutic objectives while prioritizing patient safety.

Key responsibilities

• Lead and oversee the end‑to‑end clinical operations function, including Phase I‑IV trials.
• Develop and implement operational strategies that improve trial timelines, quality, and cost‑effectiveness.
• Ensure compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), ICH guidelines, and FDA regulations.
• Manage cross‑functional teams and external partners such as CROs, sites, and vendors.
• Drive continuous improvement, innovation, and a culture of collaboration within the clinical organization.

Required profile

• Minimum 15 years of experience in clinical operations within biopharmaceutical or life‑science companies.
• Proven leadership of large, cross‑functional teams in a competitive environment.
• Strong analytical ability and experience with budget development, resource allocation, and fiscal responsibility.
• Excellent communication skills and a commitment to diversity and inclusion.

Required skills

• Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) knowledge.
• Familiarity with ICH guidelines and FDA regulatory requirements.
• Clinical trial design, feasibility assessment, site selection, and patient recruitment expertise.
• Budget management and vendor negotiation, including CRO selection.
• Proficiency with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms.
• Data analysis and biostatistics applied to clinical trials.