Head of Clinical Operations

Role Overview

• Define and lead the local clinical operations strategy, ensuring alignment with global development plans and the optimal positioning of the country, including the generation of clinical evidence for new products;
• Lead end-to-end execution of clinical studies (local and global) through CROs and internal teams, ensuring adherence to timelines, budget, quality and compliance requirements;
• Drive operational excellence and continuous improvement, ensuring compliance with Good Clinical Practice (GCP), regulatory requirements and internal SOPs;
• Establish and oversee CRO governance, including performance management, vendor selection and proactive identification of risks and mitigation measures;
• Ensure quality, compliance and inspection readiness, including audits, pharmacovigilance processes and clinical risk management;
• Engage key stakeholders and the scientific community, providing guidance to investigators and overseeing external studies and scientific publications;
• Manage the area’s budget and resources, ensuring efficient allocation and cost optimization without compromising quality;
• Collaborate cross-functionally with Medical Affairs, Regulatory Affairs, Market Access and Commercial teams, ensuring integrated execution and alignment of clinical objectives;
• Lead and develop high-performance teams, fostering a culture of accountability, collaboration and continuous learning;
• Ensure appropriate document management and maintenance of the Trial Master File (TMF) in accordance with regulatory requirements;
• Anticipate and manage operational risks, ensuring contingency planning throughout the study lifecycle.

Requirements

• University degree in a health-related field;
• Advanced English language skills;
• Experience in the pharmaceutical industry and in clinical research;
• Knowledge of clinical research (clinical studies and BQV/BRD);
• Experience in vendor qualification (CROs and study centers);
• Knowledge of national and international clinical research legislation;
• Familiarity with quality management systems.

Tech Stack

• Google Cloud Platform

Benefits

• Position exclusive to Black and mixed-race professionals
• Culture of collaboration and trust
• Inclusion and diversity across all genders, ethnicities, religions and sexual orientations