NO AGENCIES - PLEASE!POSITION SUMMARY: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.
