Job Title: Associate Director, Clinical Program Management
Location: Bengaluru, Karnataka, India
Department: Clinical Program Management / Global Development Organization (GDO)
Job Level: Senior
Employment Type: Full-Time
Travel: 5–20% (local/international, as required)
Role Overview:
Takeda is seeking a highly skilled Associate Director, Clinical Program Management to lead operational strategy, planning, and execution of global clinical studies within assigned programs. The role ensures alignment with the Clinical Development Plan (CDP), delivers studies on schedule and budget, and supports innovative, patient-focused outcomes. This senior leadership position collaborates with cross-functional teams, strategic CRO partners, and external stakeholders to drive excellence in clinical operations globally.
Key Responsibilities:
Develop and implement regional operational strategies for assigned clinical programs.
Translate the CDP into operational plans, assessing scenarios for optimal execution of clinical studies.
Provide operational input into study protocols, synopses, and feasibility assessments to ensure timelines, patient burden, and study quality meet program objectives.
Oversee strategic CROs and vendor partners, ensuring compliance with ICH-GCP, local regulations, and Takeda SOPs.
Manage clinical study budgets, monitor external spend, and ensure efficient resource utilization.
Lead risk-based monitoring activities, including review and documentation of outputs, issues, and trends across sites.
Ensure inspection readiness and act as subject matter expert during regulatory audits.
Drive continuous improvement in clinical operations to enhance efficiency, quality, and cost-effectiveness.
Support business development, in-licensing, and alliance projects by providing operational due diligence and expert input.
Mentor, train, and develop junior staff, promoting a culture of knowledge sharing and operational excellence.
Foster cross-regional collaboration (e.g., Japan, Asia) and bring innovative solutions to clinical program management.
Core Competencies:
Expertise in clinical operations, study management, risk assessment, and contingency planning.
Ability to lead global, cross-functional teams and work across diverse regions and cultures.
Strong problem-solving, organizational, and conflict-resolution skills.
Effective communication skills in English and local languages; capable of influencing stakeholders at all levels.
Demonstrated innovation in operational strategies and continuous process improvement.
Qualifications & Experience:
Bachelor’s degree in Life Sciences or equivalent (advanced degree preferred).
10+ years of experience in pharmaceutical industry or CRO, with ≥7 years in clinical study management/oversight.
Experience across Phase 1–3 clinical studies and global/international programs.
Exposure to multiple therapeutic areas and ability to provide strategic operational input across programs.
Proven track record in budget management, vendor oversight, and regulatory compliance.
Why Join Takeda:
Takeda is committed to delivering better health and a brighter future through innovative therapies. Employees benefit from a collaborative, inclusive environment, competitive compensation, and opportunities for professional growth in a leading global pharmaceutical company.
Equal Opportunity Statement:
Takeda is an Equal Opportunity Employer, valuing diversity, equity, and inclusion. All qualified applicants will be considered without regard to race, gender, religion, national origin, disability, veteran status, or other legally protected characteristics.
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