Director, Clinical Operations

This is a fully remote position, open to applicants in Japan.

📋 Description

• Overall strategy and operational management of clinical trial operations.

• Responsible for overseeing the execution of clinical trials within assigned areas and regions, ensuring the achievement of quality, cost, and timeline targets.

• Management and escalation of risks associated with trial execution.

• Development of execution strategies for projects and programs.

• Recruitment, performance evaluation, career development, coaching, and organizational improvement for Clinical Managers, CRAs, and other staff.

• Management of staffing, headcount, resource forecasting, utilization rates, and personnel assignment to trials.

• Conducting regular meetings with client executives, performance reviews, escalation handling during issues, and proposing improvements.

• Improvement of SOPs, KPI management, promotion of operational excellence, business efficiency initiatives, and quality enhancement measures.

• Design and analyze clinical trials, interpreting complex medical data, and contributing to innovative treatments and therapies.

• Lead and manage the planning, execution, and overall management of clinical trials.

• Provide strategic direction and guidance to cross-functional teams.

• Collaborate with stakeholders to develop and implement clinical trial strategies.

• Ensure compliance with regulatory requirements and industry standards.

• Identify and mitigate risks to ensure the integrity and quality of trial data.

⛳️ Requirements

• Experience in line management within clinical development.

• Business-level proficiency in English: capable of discussing with Global Stakeholders via phone or video conferences.

• Bachelor's degree in life sciences or a related field; advanced degree is preferred.

• Extensive experience in clinical operations in the pharmaceutical, biotechnology, or CRO industry.

• Proven success in leading and managing clinical trials from inception to completion.

• Strong knowledge of regulatory requirements and GCP guidelines.

• Excellent communication, leadership, and problem-solving abilities.

• Willingness to travel as necessary (approximately 20%).

• Legal eligibility to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.