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About the Role
Lead complex clinical trials from study design through close-out while collaborating with cross-functional study teams, vendors and clinical research organizations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Lead cross-functional teams and global, regional or country trial delivery from design through close-out.
- Own timelines, budgets, risks, protocol input and study documentation under ICH/GCP and Regeneron SOPs.
- Oversee CTMS, TMF, trial registry compliance, vendors, CROs and audit or inspection readiness.
- Direct feasibility, site selection, activation, monitoring, investigator meetings and patient recruitment strategies.
- Monitor data quality, queries, deviations, supplies, accountability and trial performance against agreed metrics.
- Manage close-out, database lock, reconciliations, clinical study reports, CAPAs and lessons learned.
- Drive continuous improvement, innovative study execution and effective cross-functional collaboration.
- Lead CTM staff deliverables and, when assigned, supervision or unmasked study activities.
Requirements
- Bachelor’s degree and at least eight years of relevant industry experience.
- Extensive global clinical trial operations experience and knowledge of ICH/GCP and regulatory requirements.
- Advanced project, budget and vendor management, cross-functional leadership and organizational skills.
- Advanced proficiency with trial management systems, Microsoft applications, IVRS/IWRS and EDC.
- Expert data-driven planning, problem-solving, negotiation, communication, prioritization and stakeholder influence.
- Ability to build and develop study teams; line management experience is preferred.
- Awareness of relevant industry trends and a proactive, self-disciplined approach.
Location
- Tokyo, Japan
Work Type
- Hybrid
- Full-time
Experience Level
- Senior
Education Level
- Bachelor's degree
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.