Clinical Research Medical Advisor

Novartis; Mumbai City; On-site; INR 2,400,000 - 4,200,000; Full time

Job summary

Novartis is seeking country-level clinical and medical leadership in Mumbai to drive feasibility, protocol execution, and recruitment strategy for clinical development programs.

You will collaborate with investigators, regulators, and internal teams to ensure high-quality trial delivery while maintaining safety and regulatory compliance. Requires MD-type qualification with global standards exposure and 1–3+ years in the field.

Qualifications

• MD/MBBS/PhD/PharmD with MD preferred; Real-World Evidence experience advantageous.
• 1–3+ years in pharmaceutical clinical development or clinical practice with understanding of end-to-end drug development.
• Strong knowledge of ICH-GCP guidelines, clinical research regulations, patient safety requirements, and trial conduct standards.
• Proven ability to lead multidisciplinary teams, manage scientific and operational complexities, and drive stakeholder alignment.

Responsibilities

• Assess Clinical Trial Feasibility by validating study designs and protocol feasibility based on medical practice, patient availability, and competitive landscape.
• Drive Trial Start-up Success through scientific and medical contribution during study start-up for faster site activation.
• Provide Clinical and Medical Expertise to operations teams and trial sites for protocol implementation, IRB/EC submissions, informed consent reviews, and regulatory interactions.
• Lead Scientific Stakeholder Engagement with investigators, regulators, KOLs, advisory boards, patient groups, and external experts.
• Develop Clinical Trial Strategies addressing recruitment, retention, and data quality with mitigation plans for study delivery.
• Build Disease Area Knowledge and deliver training on indications, compounds, and protocols to internal teams and external stakeholders.
• Optimize Patient Recruitment leveraging physician insights, competitive intelligence, and innovative approaches.
• Partner Cross-Functionally with Clinical Development, Medical Affairs, Regulatory, Safety, HEOR, Patient Access, and Clinical Operations.
• Ensure Patient Safety and Data Quality by supporting pharmacovigilance activities and ensuring compliance with GCP, ICH, and local regulations.
• Represent Clinical Development Leadership by supporting inspections, audits, and real-world evidence initiatives.

Skills

Clinical Research

Clinical Trials

Drug Development

Health Sciences

Immunology

Internal Medicine

Medical Information

Patient Care

Stakeholder Engagement

Education

MBBS/MD/PhD/PharmD

Job description

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 innovative 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, and maintaining compliance with GCP, ICH, and local regulations.
• Represent Clinical Development Leadership by driving country-level clinical and medical activities, supporting inspections and audits, contributing to innovative study designs and real-world evidence initiatives, and enhancing Novartis’ reputation with investigators and sites.

Essential Requirements

• MBBS/M.D., Ph.D., or Pharm.D. required, with an M.D. highly preferred; subspecialty training and/or Real-World Evidence (RWE) experience is advantageous.
• 1-3+ years of experience in pharmaceutical clinical development or clinical practice, with a strong understanding of the end-to-end drug development process.
  Solid understanding of ICH-GCP guidelines, clinical research regulations, patient safety requirements, and clinical trial conduct standards.
• Proven ability to lead and influence multidisciplinary teams, manage scientific and operational complexities, delegate effectively, and drive stakeholder alignment.
• Demonstrated capability to solve complex clinical and operational challenges, adapt across therapeutic areas, and deliver high-quality scientific presentations and training.

Skills Desired

Clinical Research, Clinical Trials, Drug Development, Health Sciences, Immunology, Internal Medicine, Medical Information, Patient Care, Stakeholder Engagement