Senior Manager, Clinical Study Lead

About the role

Regeneron, a biopharmaceutical company developing medicines for serious diseases, is looking for a Senior Clinical Study Lead to join its Clinical Trial Management team in Tokyo, Japan. The role supports global, regional and country studies in a hybrid arrangement, leading complex clinical trials from design through close-out while working with cross-functional teams, vendors and CROs.

Key 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 and lead CTM staff deliverables, including supervision or unmasked study activities when assigned

Required profile

• 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
• Ability to build and develop study teams; line management experience preferred
• Awareness of industry trends and a proactive, self-disciplined approach

Required skills

• Advanced proficiency with trial management systems, Microsoft applications, IVRS/IWRS and EDC
• Data-driven planning, problem-solving, negotiation, communication, prioritization and stakeholder influence

The role is hybrid with up to 25% travel. Regeneron offers a total rewards package that may include annual bonuses, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off and family support benefits, depending on country and role.