Job Description

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

What You'll Do

· Serve as the senior representative for Japan, contributing to country strategy and representing CTI internally and externally (e.g., sponsors, PMDA, key vendors, and partners).

· Build strong relationships with clients, sites/institutions, PIs, PMDA, vendors and partners, ensuring alignment with CTI’s global operations and strategic goals.

· Provide leadership and oversight to Japan-based staff, supporting recruitment, onboarding, training, mentoring, and support country staff performance management.

· Represent Clinical Project Management services in client presentations and business development activities.

· Promote integration of Japan operations with regional and global teams, fostering collaboration and knowledge sharing.

· Serve as a senior liaison for Japan opportunities, supporting CTI BD Sales and Regional Operations leadership through strategic input on business development proposals and active participation in project budget preparation and review.

· Develops and supports marketing and branding initiatives in Japan, including representing CTI at industry conferences, and other key events.

· Support the development and review of Japan-specific SOPs, ensuring compliance with local requirements while maintaining alignment with regional and global standards.

· Monitor the progress of all clinical trials in Japan, addressing country and/or region-specific issues as needed.

· Ensure operational readiness, business continuity, and resource efficiency across Japan activities.

· Serve as the escalation point for Japan-based activities across country, regional, and global studies.

· May serve as Project Director for global or regional studies

· Support the development and maintenance of company policies and procedures specific to Japan.

· Collaborate with finance, legal and HR departments to manage external vendors for tax compliance, accounting, and payroll services.

· Oversee and approve monthly, quarterly, and annual accounting and financial reporting activities in coordination with the finance team.

· Manage logistics and administrative tasks for the Japan team, including office administration, supporting corporate regulations according to Japan laws, rentals, and running expenses.

· May provide clinical and regulatory strategy support to other Asian countries as needed.

IF HAS A MEDICAL-RELATED EDUCATIONAL BACKGROUND:

• Serve as the primary liaison with legal and regulatory authorities, including the PMDA, ensuring full compliance with both local and international laws and regulations.
• Lead as the ICCC (In-Country Clinical Caretaker), ensuring strategic alignment between global clinical operations and local execution.
• Provide regulatory consulting support as needed, offering strategic guidance to internal teams and external clients.
• Oversee all PMDA submissions, from initial dossier preparation through study closure, ensuring accuracy and timeliness.
• Maintain continuous audit readiness and full compliance with PMDA requirements, including all mandated reporting timelines (e.g., safety reports, annual updates), and ensure adherence to ICH-GCP standards in close collaboration with Global QA, Regulatory Affairs, and Vendor Management teams.
• Conduct training sessions for company employees on applicable Japanese regulatory requirements to ensure organizational compliance and awareness.

What You'll Bring

• Excellent verbal and written communication skills
• Knowledge of PMDA regulatory requirements and guidelines (i.e International Conference of Harmonization [ICH] and GCPs) preferred
• Knowledge of medical and pharmaceutical terminology
• Ability to effectively communicate information both verbally and in writing
• Ability to define and execute country-level strategies aligned with global objectives.
• Ability to travel domestically and internationally
• Ability to work independently
• Ability to multi-task, track, and maintain organization in fast-paced, changing environment
• Ability to use good judgment when making decisions
• Ability to provide highest level of customer service
• Ability to build strong bonds to foster open, honest, and candid communication
• Ability to maintain highest level of confidentiality when dealing with proprietary information and sensitive situations
• Ability to effectively use technology and software systems
• Ability to identify client needs/opportunities and translate them into new projects
• Ability to interact and develop a rapport with clients
• Strong change management skills and experience leading operational transitions.
• Strong decision-making and problem-solving skills in a complex, regulated environment.
• Strong understanding of CRO industry.

Required EDUCATION AND EXPERIENCE

• +15 years of clinical research experience
• +5 years of business development and client management experience
• Experience working in global CROs or pharmaceutical companies, managing global, regional, and country-level studies involving Japan.
• Advanced knowledge of applicable regulatory requirements and related guidelines, with the ability to apply them effectively.Experience supporting Japan operations in areas such as legal, HR, tax, and finance.
• Bachelor’s degree in business administration or allied health field such as medicine, pharmacy or health science, preferably with clinical trial management experience
• Preferred: Master’s degree in life sciences, healthcare, or business administration

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process