Clinical Research Medical Advisor

Novartis India; Mumbai; On-site; INR 2,000,000 - 3,500,000; Full time

Job summary

Novartis India is seeking a country-level clinical and medical leader to drive protocol feasibility, investigator engagement, recruitment strategy, and high-quality trial execution across clinical development programs.

You will collaborate with internal and external stakeholders to bring innovative medicines to patients faster while maintaining the highest standards of safety and regulatory compliance, and you will lead scientific engagement with investigators and regulators.

Qualifications

• MBBS/MD/PharmD required, MD preferred.
• 1–3+ years in pharmaceutical clinical development or clinical practice.
• Solid understanding of ICH-GCP guidelines and regulatory requirements.

Responsibilities

• Assess clinical trial feasibility and protocol feasibility decisions.
• Drive trial start-up and enable faster site activation.
• Provide clinical and medical expertise for protocol implementation and regulatory submissions.
• Lead scientific stakeholder engagement with investigators and regulators.
• Develop trial strategies addressing recruitment and data quality.
• Build disease area knowledge and deliver training.
• Optimize patient recruitment through insights and engagement.
• Partner with cross-functional teams to support study execution.
• Ensure patient safety and data quality, monitoring pharmacovigilance.
• Represent development leadership in inspections and audits.

Skills

Leadership

Stakeholder management

GCP/ICH knowledge

Clinical trial expertise

Education

MBBS/MD/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

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 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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we'll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)

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