Senior Director Clinical Operations

Position Summary

The Senior Director of Clinical Operations is responsible for supporting business objectives by directing the delivery of high-quality and compliant clinical study operations and clinical safety management in the areas of clinical study development and execution. They are also responsible for resource management and development for the Operations and Safety team members. In partnership with the Leadership Team, the Clinical Operations Manager will lead the development, evaluation, and revision of internal clinical processes and procedures.

Essential/Key Job Responsibilities:

• Perform supervisor responsibilities for direct reports, including but not limited to performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions.
• Identify team members' development needs or potential and provide or recommend project assignments and training to increase expertise to meet current or future business needs.
• In collaboration with the leadership team, oversee the daily activities of Clinical Affairs personnel, including projects, resources, timelines, and budget, through a direct-line or dual-line reporting structure.
• Develop and oversee Clinical Affairs metrics reporting. Provide regular and ad hoc reporting of metrics to the Leadership Team and others.
• Assist in developing and coordinating global Clinical Affairs Operations project, resources, timelines, and budgets.

Required Qualifications:

• At least seven years of experience in the Clinical Research/Medical device Industry.
• 4+ years’ experience in managing clinical research studies.
• 3+ years’ experience managing or directly mentoring personnel.
• Strong working knowledge of Good Clinical Practices, FDA regulations, ISO standards, and current industry practices related to the conduct of clinical trials.
• Excellent communication skills (oral and written).
• BA/BS in health science field, MA/MS preferred.