Clinical Operations Director
Tokyo 23 Wards
¥15,000,000 - ¥18,000,000
Expanding US Bioventure with Breakthrough Therapy in Rare Disease Area
Lead Global APAC Level Clinical Studies
About Our Client
- US Headquartered Bio-pharmaceutical company with approved product in the immunological rare disease area.
- Expanding development pipeline in US as well globally
- Act as the primary operational lead for APAC region across all compound(s).
- Ensure consistent and successful execution of all operational aspects of regional and global studies as appropriate, including staff resourcing, timelines, budget, data delivery and reporting, vendor management, GCP, etc.
- The position will be required to contribute to the strategic development of early and late-stage clinical program.
- Develop operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and other cross functional departments.
- Accountable for timely study start-up in APAC region including country submissions, site activations, and screening/enrolment activity.
- Provide oversight of feasibility, site selection, and site/country modelling for final selection recommendations.
- Act as key liaison with Key Opinion Leaders and MSLs within APAC region.
- Ensure a "Quality Mindset" is in place across the organisation by focusing on detailed plans to monitor the conduct of our studies, the management of our vendors and working closely with our QA organisation to implement and manage a process for Inspection Readiness.
- Member of the Clinical Operational Leadership Team to assist in the delivery of regional and global
objectives and implementation of process improvements.
The Successful Applicant
- University degree, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred
- Extensive experience in clinical operations within a senior leadership position for the global pharmaceutical or CRO industry
- Good experience of clinical development / drug development process in various phases of development and therapy areas.
- Knowledge of process improvement methodology
- Evidence of developing partnering skills
- Native level Japanese
- Business level English
What's on Offer
- Contribute to expansion of a promising global bio-pharmaceutical company in Japan
- Opportunity to lead APAC level projects