Head clinical research

• Develop and execute clinical development strategies that align with the organization's goals and timelines
• Provide leadership to cross-functional teams, including Clinical Sciences, Clinical Quality & Compliance, Statistics Data Management, Clinical Pharmacology, and Clinical Operations
• Ensure alignment of clinical activities with regulatory requirements, industry standards, and best practices
• Oversee the design, implementation, and management of all clinical studies, from Phase I to Phase IV
• Ensure that clinical trials are conducted according to GCP (Good Clinical Practice) guidelines, ICH (International Conference on Harmonization) standards, and other relevant regulations
• Lead the Clinical Quality & Compliance team to ensure adherence to regulatory requirements and company policies
• Develop and maintain systems for quality assurance, auditing, and inspection readiness for clinical trials
• Ensure compliance with data privacy regulations (e.g., GDPR, HIPAA) in data management and clinical operations
• Oversee the Statistics Data Management team to ensure robust data collection, analysis, and interpretation
• Collaborate with biostatistics, data managers, and clinical scientists to ensure the accuracy of clinical study data and its alignment with regulatory submission requirements

• MD or PhD in Medicine, Pharmacology, Clinical Research or equivalent with 15 years of experience (5 years in leading cross-functional team)
• Prior experience working with global regulatory agencies such as the FDA, EMA, etc.
• Experience in biologics/CGT experience desirable
• Familiarity with pharmacovigilance and safety monitoring in clinical trials

Experience in biologics/CGT experience desirable