Provide strategic leadership and operational oversight to the Global Clinical Operations team.
Develop and implement standard operating procedures (SOPs) in line with regulatory compliance requirements, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines.
Lead the planning, initiation, execution, and completion of global clinical trials, ensuring they are conducted in compliance with all applicable regulations and standards.
Foster strong relationships with investigators, medical professionals, regulatory authorities, and other stakeholders.
Oversee the preparation of clinical trial budgets, contracts, and timelines.
Ensure the accurate and timely reporting of clinical trial data and results.
Drive the continuous improvement of clinical operations processes and systems.
Provide mentorship, guidance, and professional development opportunities to the Clinical Operations team.
Qualifications
Advanced degree (MS, PhD, PharmD, or MD) is preferred.
Minimum of 10 years of senior leadership experience in clinical operations within the pharmaceutical
Demonstrated experience in the strategic planning and execution of global clinical trials within radiopharmaceuticals.
Strong working knowledge of regulatory compliance requirements, SOPs, GLP, GCP, and ICH guidelines.
Excellent leadership and team management skills, with the ability to inspire and motivate a high-performing global team.
Strong strategic thinking and problem-solving skills, with the ability to make sound decisions in a fast-paced environment.
Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders at all levels.
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