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