Position Summary:   

The Director, Clinical Operations is lead operational contact for clinical studies and provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will also support the business by leading, mentoring, and developing the Clinical Operations team, fostering a collaborative and high-performance culture, providing strategic direction and managing all aspects of the study management, including budget, resources, and development initiatives. 

Essential Duties and Responsibilities: 

• Develop and implement clinical operations strategies to support the company's product pipeline, ensuring alignment with corporate goals and objectives. 
• Lead and oversee the strategic planning, implementation and execution of clinical trials in accordance with project timelines, budget, and quality standards 
• Develop and manage comprehensive site management plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies 
• Collaborate cross functionally with internal teams to ensure the alignment on clinical trial objectives and milestones and the successful execution and monitoring of clinical trials. 
• Serve as the point of contact for CROs and vendors, overseeing their site management performance and ensuring adherence to contractual agreements, timelines and quality standards  
• Track accrued site operations and monitoring expenditure against the actual budget for each program 
• Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct 
• Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity 
• In collaboration with the Head of Clinical Operations, hire, train, develop, and mentor the Clinical Operations/Clinical Research Associate team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence 
• Identify and solve problems that may arise during the trial. 
• Continuously evaluate and improve clinical trial processes. 
• Direct reports: manage and direct external and/or internal clinical trial managers and clinical monitors. 
• Travel may be required. 

Other Duties: 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

Required Education and Experience: 

• BS or BA (Life Sciences preferred) or certification in related allied health profession from an appropriately accredited institution 
• Minimum 10 years relevant clinical operations experience including demonstrated skills and competency in project management tasks 
• Broad knowledge of drug development process 
• Detailed knowledge of the following: 
• Project management processes 
• Time and cost estimate development  
• ICH Guidelines and international regulatory requirements for clinical and site management 
• Experience managing: 
• Multiple regions and/or vendors 
• Operational teams and clinical research associates 

Required Knowledge, Skills, Abilities & Behaviors:  

• Demonstrated ability to handle multiple competing priorities 
• Demonstrated ability to manage, lead, and inspire clinical teams and motivate staff within a matrix system 
• Demonstrated ability to lead by example and to encourage team members to seek solutions independently  
• Excellent written and verbal communication skills, and planning and organization skills 
• Ability to work independently with internal and external groups on multiple projects 
• Ability to negotiate and liaise with vendors in a professional manner 
• Ability to travel domestically and internationally 
• Proven ability to develop and manage high-performing teams. 
• Understanding of clinical trial regulations and best practices. 

Work Conditions: 

• This job operated in a professional office environment.  
• This role routinely uses standard office equipment such as computers, phones and photocopiers. 
• This position is required to work occasional nights and weekends to meet company demands.