Job Description

NO AGENCIES - PLEASE!

Please note: This position requires the individual to be on-site (no remote work). Relocation assistance is not provided.

The Director of Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed-upon timelines and budgets. This role reflects the knowledge, experience, skill levels, and capacity to manage complex studies or programs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Strategic Planning:

• Develop and execute strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.

Clinical Trial Management:

• Oversee the design, planning, and execution of clinical trials, including Phase I-III studies, ensuring adherence to timelines, budgets, and quality standards.
• Lead the selection and management of Contract Research Organizations (CROs) and vendors involved in clinical trials.
• Monitor clinical trial progress and identify and mitigate risks and issues that may impact timelines or data quality.

Regulatory Compliance:

• Ensure all clinical operations activities are conducted in compliance with applicable regulatory guidelines, including Good Clinical Practice (GCP) and local regulations.
• Collaborate with regulatory affairs to support regulatory submissions and interactions with health authorities.

Resource Management:

• Build and manage a high-performing clinical operations team, including hiring, training, and development of staff to oversee studies.
• Oversee the allocation of resources, including budget management and forecasting for clinical trial activities

CRO Collaboration:

• Manage and collaborate effectively with CRO partners, ensuring their performance aligns with project timelines, quality standards, and budgetary constraints.
• Manage vendor relationships and negotiate contracts to ensure efficient and cost-effective clinical trial execution.

Data Management and Analysis:

• Collaborate with data management and biostatistics teams to ensure data collection, analysis, and reporting are of the highest quality.
• Review and interpret clinical trial data to support decision-making and data-driven insights.

Quality Assurance:

• Implement and maintain quality assurance processes to ensure the integrity of clinical trial data and compliance with regulatory standards.

Continuous Improvement:

• Drive continuous improvement initiatives within clinical operations processes to optimize efficiency and effectiveness.
• Other duties, as assigned.

QUALIFICATIONS

• Ph.D. is preferred; however, Master’s Degree in life sciences or a related field would be the required minimum.
• Minimum of 10 years of experience in clinical operations within the biotechnology or pharmaceutical industry, with significant experience in CNS therapeutic areas.
• Proven track record of successful leadership in managing and executing Phase II-III clinical trials.
• Strong understanding of regulatory requirements and GCP guidelines.
• Excellent leadership and team-building skills.
• Exceptional communication and interpersonal skills.
• Strategic thinker with the ability to make data-driven decisions.
• Proven ability to work collaboratively in a cross-functional environment, do what is right, create value, and achieve the extraordinary.