Manager, Clinical Operations - Japan

4w1 month ago

Takeda

Osaka, JP · Full-time

About this role

As a Clinical Program Manager within Takeda's Japan Development Center, you will take ownership of the execution strategy and management of clinical trials, with a strong focus on oncology. This role is central to Takeda's mission of delivering innovative medicines to patients by ensuring quality, speed, and cost discipline across all trial activities.

In this position, you will oversee the entire lifecycle of clinical studies, from early-stage trials through to regulatory submission and international collaborative studies. Your day-to-day work involves leading study teams, managing CRO oversight, developing and managing budgets, and evaluating in-licensed compounds for clinical trial feasibility.

You will collaborate extensively with internal and external stakeholders, including global development teams, CRO partners, and local cross-functional departments based in Tokyo or Osaka. The role offers high flexibility in working style, with remote work being the norm, allowing you to focus on driving trial momentum while managing complex partnerships.

This role provides a unique opportunity to grow as a clinical development expert, building deep expertise in oncology while developing program management skills and adaptability across global and local development frameworks. The work directly connects to the profound satisfaction of accelerating patient access to new therapies.

Requirements

5+ years of experience in Clinical Operations at a pharmaceutical company or CRO, with demonstrated ability to lead and manage clinical studies as a study leader
Substantial experience in clinical drug development, including early- to late-stage trials, regulatory submissions, and international collaborative studies
Experience in oncology drug development is strongly preferred
Experience as a project leader or project manager within a development team at a pharmaceutical company or CRO is preferred
Experience working collaboratively with global development teams is preferred
Business-level English communication skills, both verbal and written, sufficient to interact with international counterparts
Ability to manage complex stakeholder relationships across internal and external teams

Responsibilities

Develop clinical trial execution strategies and plans, particularly for early-stage approval pathways
Manage clinical trial operational activities, ensuring quality, speed, and cost discipline
Oversee CRO partners, including oversight of study-related contracts, deliverables, and performance
Prepare and manage clinical trial budgets, including forecasting and tracking expenses
Evaluate in-licensed compounds and new projects for clinical trial implementation feasibility
Collaborate with global and local cross-functional teams to align on trial execution and regulatory strategy
Lead study teams as a study leader, driving study milestones and managing risk

Benefits

Flexible work styles including flextime and telework (remote work is the primary mode)
Annual salary increase and bonus payments (twice a year)
Commutation, housing, and overtime allowances
Comprehensive social insurance, retirement and corporate pension plans, and employee stock ownership program
Paid leave including annual, special, sick, family support, maternity, childcare, and family nursing leave
Approximately 123 holidays per year (Saturdays, Sundays, national holidays, May Day, year-end holidays)