Associate Director – Clinical Program Management
Location: Bengaluru, Karnataka, India
Job Type: Full-Time | Senior Level
Job ID: R0163476
About Takeda
At Takeda, we are committed to creating better health for people and a brighter future for the world. Our Global Development Organization (GDO) focuses on study management, clinical trial innovation, clinical supply chain, and patient safety to ensure the highest quality and predictable delivery of our innovative pipeline. We leverage data, analytics, and digital technologies to accelerate clinical development while maintaining global regulatory compliance.
Role Overview
We are seeking an Associate Director – Clinical Program Management to lead study operational strategy, planning, and execution for assigned clinical programs. This role provides strategic and operational oversight to ensure studies are delivered on time, on budget, and in compliance with ICH-GCP, local regulations, and Takeda SOPs. The position also involves mentoring and developing clinical operations staff and collaborating with cross-functional teams and strategic partners globally.
Key Responsibilities
Lead operational strategy and planning for assigned clinical programs, ensuring alignment with Clinical Development Plans (CDP).
Oversee execution of clinical studies, ensuring quality, timelines, and budget compliance.
Manage and provide strategic oversight of CROs and external vendors, including review of risk-based monitoring outputs and inspection readiness.
Contribute operational expertise to protocol development, Investigator Brochures, study synopsis, clinical study reports, and regulatory meeting preparation.
Lead budget planning and monitoring for clinical studies, coordinating with Finance and Outsourcing teams.
Actively identify opportunities for process improvement, efficiency, and cost reduction in clinical operations.
Provide mentorship and training to less experienced staff, supporting talent development within Clinical Operations.
Participate in business development, in-licensing, and alliances evaluations, providing operational due diligence.
Promote cross-regional collaboration (e.g., Asia, Japan) and contribute innovative solutions to enhance clinical trial execution.
Core Competencies
Expert in clinical study management, scenario assessment, risk assessment, and contingency planning.
Strong cross-functional leadership, able to influence and collaborate across regions and functions.
Proficient in regulatory and compliance requirements for clinical development.
Excellent teamwork, communication, organizational, problem-solving, and conflict resolution skills.
Talent development and mentorship experience.
Ability to drive innovation and operational excellence within global clinical programs.
Qualifications & Experience
Bachelor’s degree in Life Sciences (or equivalent); advanced degree preferred.
10+ years in pharmaceutical industry and/or clinical research organization.
7+ years of clinical study management/oversight, including Phase 1, 2, and 3 studies.
Experience in global or international clinical programs across multiple therapeutic areas.
Fluent in English and local language.
Travel
5–20% travel required, including local and international visits to Takeda sites and strategic partners.
Why Join Takeda
Lead high-impact global clinical programs with direct influence on patient outcomes.
Work in a collaborative and inclusive environment, driving innovation in clinical development.
Access opportunities for career growth, learning, and leadership development.
Contribute to transformative therapies with a company that values honesty, integrity, and excellence.
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time | Senior Level
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