Senior Clinical Research Director

Senior Clinical Research Director

The Senior Clinical Research Director will oversee and lead clinical trials and research studies, ensuring timely completion within budgetary constraints and adherence to regulatory standards. This key leader will supervise research teams, collaborate with cross-functional departments, and provide strategic direction for clinical research activities.

• Develop and implement clinical research strategies and plans from start to finish.
• Oversee the execution of clinical trials, ensuring compliance with protocols, timelines, and budgets.
• Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
• Provide oversight on the recruitment, enrollment, and monitoring of clinical trial subjects.
• Manage relationships with clinical research organizations (CROs), investigators, and external vendors.

Team Leadership:

• Lead and mentor clinical research staff, ensuring they are trained and performing effectively.
• Assign tasks and responsibilities to team members based on project needs.
• Develop training programs and provide ongoing professional development for research teams.

Regulatory Compliance:

• Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.
• Monitor compliance with federal, state, and local regulations, as well as company policies.
• Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards.

Study Design & Protocol Development:

• Collaborate with scientific and medical teams to develop clinical trial protocols.
• Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
• Evaluate feasibility and risk of proposed studies.

Data Management and Reporting:

• Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
• Review and analyze clinical trial data to ensure quality and integrity.
• Prepare and present progress reports to senior leadership and stakeholders.

Budget and Resource Management:

• Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.
• Oversee resource allocation, including personnel, equipment, and communication.

Communication:

• Foster collaboration between internal teams, external partners, and key stakeholders.
• Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution.
• Resolve any issues related to clinical trial execution and provide solutions.

Required Skills and Qualifications:

The ideal candidate will have a degree in Life Sciences, Clinical Research, or a related field (Master's or higher) with at least 2-3 years of experience in a managerial or supervisory role. In-depth knowledge of clinical trial management, regulatory requirements, and strong project management, leadership, and organizational skills are essential. Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders, are also required. Proficiency in clinical research software and data management systems is preferred. A Research Coordinator (CRC) or Clinical Research Associate (CRA) certification is also desirable.

Working Conditions:

Full-time, in-office or remote, with occasional travel required to clinical trial sites and partner organizations.