• 12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff.
• Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to the conduct of regulated clinical trials.
• Comprehensive understanding of applicable clinical research regulations. Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
• Extensive experience in designing, managing and interpreting clinical studies. Knowledge of clinical research methodologies and market research strategies.
• Effective planning and project organization skills, including risk assessment and contingency planning.
• Strong people management and team motivation skills. Ability to attract highly talented clinical operations staff.
• Demonstrated management, negotiation and cross-functional collaboration skills. Excellent verbal and written communication and presentation skills.
• Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.
• Ability to travel as required (up to 25%).
As Head of Clinical Operations, you will drive the clinical development strategies by playing a lead role in the design of the company’s clinical studies and programs. You will lead the strategic application and tactical execution including management, planning, and implementation of clinical studies and programs. Your guidance and learning throughout the planning and implementation phases will ensure clinical operations timelines are met across the organization. The position also includes responsibility to set direction for the Clinical Operations organization including hiring and mentoring of staff.
• Oversee the company’s Clinical Operations activities and implementation of clinical studies and development programs.
• Ensure operational feasibility of clinical development plans, including timeline, budget and resource requirements.
• Ensure that all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOPs.
• Set the direction of the Clinical Operation organization and lead strategic discussions regarding program and study resourcing.
• Hire, supervise and train operations personnel and assume ownership of the quality of clinical deliverables.
• Procure CRO and vendors and provide oversight throughout the life of all assigned activities. Ensure transparency for costs, deliverables and quality expectations.
• Define patient recruitment strategies and ensure operational feasibility and timely implementation of the set study goals.
• Work with other Medical/Clinical team members on study documents including clinical trial protocol and amendments, ICFs, CRFs, IND, IB, CRO contracts, study reports, etc.