07 Oct
|
Novartis India
|
Mumbai
07 Oct
Novartis India
Mumbai
Summary
Provide country-level clinical and medical leadership for Novartis clinical development programs by driving protocol feasibility, investigator engagement, recruitment strategy, and high-quality trial execution. Collaborate with internal and external stakeholders to bring innovative medicines to patients faster while maintaining the highest standards of safety and compliance
About The Role
Major Accountabilities:
• Assess Clinical Trial Feasibility by validating study designs and making final decisions on protocol feasibility based on medical practice, patient availability, and competitive trial landscape.
• Drive Trial Start-up Success through active scientific and medical contribution during study start-up, enabling faster site activation and execution.
• Provide Clinical and Medical Expertise to clinical operations teams and trial sites for protocol implementation, IRB/EC submissions, informed consent reviews, and regulatory interactions.
• Lead Scientific Stakeholder Engagement with investigators, regulatory authorities, key opinion leaders, advisory boards,
patient advocacy groups, and other external experts.
• Develop Clinical Trial Strategies that anticipate recruitment, retention, and data quality challenges while creating mitigation plans to ensure successful study delivery.
• Build Disease Area Knowledge and deliver indication, compound, and protocol training to internal teams and external stakeholders to improve trial awareness and recruitment.
• Optimize Patient Recruitment by leveraging physician insights, competitive intelligence, patient engagement, and creative approaches to strengthen enrollment strategies.
• Partner Cross-Functionally with Clinical Development, Medical Affairs, Regulatory, Safety, HEOR, Patient Access, and Clinical Operations teams to support study execution and product strategy.
• Ensure Patient Safety and Data Quality by supporting pharmacovigilance activities, reviewing serious adverse events, resolving medical issu
📌 Clinical Research Medical Advisor (Mumbai)
🏢 Novartis India
📍 Mumbai