Location: Mumbai, Maharashtra, India | Job Type: Full-Time | Work Model: Hybrid | Travel: 15–25%
Job Category:
Medical Affairs / Clinical Science
Oncology / Hematology
Clinical Development & Operations
Leadership / Executive
About the Role:
Takeda is a global biopharmaceutical leader committed to advancing science to transform patient lives. We are seeking a Senior Medical Director, Clinical Science – Oncology to lead and strengthen our oncology clinical development operations in India. This role is ideal for a patient-focused, innovation-driven professional with strong expertise in oncology, clinical strategy, and cross-functional leadership.
As Senior Medical Director, you will drive clinical trial execution, oversee clinical science activities, and serve as a key medical and therapeutic area expert. You will lead the India OTAU R&D team, support global development strategy, and foster investigator networks to accelerate oncology innovation.
Key Responsibilities:
Clinical Strategy & Execution
Lead India OTAU oncology R&D strategy in alignment with global goals.
Develop and execute integrated clinical development plans, protocols, and program strategies for oncology pipeline assets.
Provide oversight for study execution, data interpretation, and clinical monitoring activities.
Ensure compliance with ICH-GCP, global regulations, and local requirements.
Leadership & Team Management
Lead, mentor, and develop the India oncology clinical science team.
Promote a high-performing, collaborative, and inclusive team culture.
Manage cross-functional teams across multi-regional studies, including US, EU, and Asia.
External Engagement & Investigator Relations
Build and maintain strong relationships with KOLs and clinical investigators in India.
Represent Takeda in regulatory, scientific, and alliance meetings.
Advise on clinical trial feasibility, site selection, and patient engagement strategies.
Regulatory & Medical Oversight
Contribute to NDA/MAA submissions and other regulatory filings.
Provide guidance on trial safety monitoring, risk management, and protocol compliance.
Review clinical data to inform go/no-go decisions, product labeling, and development strategy.
Business Development & Alliance Support
Participate in due diligence, partnership evaluations, and clinical development planning for alliances or in-licensing opportunities.
Serve as clinical liaison for ongoing alliances, ensuring alignment with strategic objectives.
Qualifications & Experience:
Education:
MD, MD/PhD, or internationally recognized equivalent.
Clinical training in Medical Oncology or Malignant Hematology preferred.
Experience:
5–7 years of clinical research experience in pharma, CROs, or academia.
4–5 years of people management experience in healthcare or life sciences.
Proven track record of leading multi-regional oncology clinical development teams.
Experience with NDA/MAA submissions is a plus.
Skills & Competencies:
Deep expertise in oncology therapeutic areas, including solid tumors and hematologic malignancies.
Strong leadership, strategic thinking, and cross-cultural collaboration skills.
Exceptional medical writing, communication, and interpersonal skills.
Knowledge of global regulatory standards (ICH-GCP, GVP) and local compliance requirements.
Ability to anticipate challenges and implement proactive solutions.
Experience with investigator engagement, clinical trial innovation, and site network development.
Travel:
Approximately 15–25%, including domestic and limited international travel.
Why Takeda:
Work with a global leader in oncology R&D.
Lead high-impact clinical programs in India with international collaboration.
Access to professional development, mentorship, and opportunities to shape innovative clinical science initiatives.
Join a diverse, inclusive, and values-driven workplace committed to better health outcomes worldwide.
Apply Now to become part of Takeda’s mission to transform lives through cutting-edge oncology research.
Gujarat :
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Siliguri |Illinois :
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