29 Aug
|
Novartis
|
Mumbai
Job Description 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
Job Description
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 issues,
📌 Clinical Research Medical Advisor (Mumbai)
🏢 Novartis
📍 Mumbai