Medical Expert
Job ID: REQ-10047664
April 8, 2025
Location: India
Summary
The Medical Expert in Translational Clinical Oncology (TCO) acts as the medical leader for assigned global, roll-over, and long-term follow-up studies, and studies in the close-out phase. They may also provide medical co-leadership for aspects of one or more global, active TCO studies, under the guidance of a Clinical Program Leader (CPL). TCO is a department under the Biomedical Research division responsible for designing and executing early-phase clinical studies in patients with cancer, bridging drug discovery with late-phase clinical development.
Key Responsibilities:
Medical Leadership & Support
Provide medical support to the Clinical Program Leader (CPL) for clinical protocols, amendments, Informed Consents, publications, regulatory documents (e.g., Investigator Brochures, Health Authority responses), and review of clinical trial data.
Act as the medical monitor for safety reporting, collaborating with the Patient Safety Team on Drug Safety Update Reports (DSURs) and other safety-related documents.
Represent CPL at project team meetings (e.g., CTT), teleconferences, and site initiation visits.
Clinical Trial Management
Oversee clinical/scientific elements of TCO-related submission documents, including preparation of project documentation for Health Authority submission, briefing books, Annual Safety Reports, etc.
Lead the ongoing medical/scientific review of clinical trial data and coordinate data analysis and interpretation.
Manage close-out, roll-over, and long-term follow-up studies, ensuring high-quality Clinical Study Report (CSR) review in collaboration with the medical writing team.
Stakeholder Engagement & Mentorship
Engage with internal and external stakeholders, managing relationships and ensuring continuous communication.
Mentor and coach junior TCO team members in India, enhancing their knowledge and skills.
Advocate for continuous quality improvement and ensure adherence to company standards and local regulations.
Knowledge & Training
Maintain expertise in ICH-GCP, regulations, and Novartis SOPs. Assist with training across TCO India on relevant processes and best practices.
Key Performance Indicators:
Management of assigned studies to ensure execution according to timelines and high-quality standards, adhering to international and local regulations.
Evidence of quality medical review of trial data and contributions to clinical documents (protocols, IBs, DSURs, CSRs).
Feedback from stakeholders on scientific and operational contributions.
Demonstrated commitment to Novartis Values and Behaviors.
Minimum Requirements:
Education:
MD or equivalent medical degree required.
Advanced clinical training in areas like internal medicine or pharmacology with medical council certification.
Experience:
At least 5 years of experience in the pharmaceutical/biotech industry.
At least 2 years of clinical practice experience in a hospital setting.
Experience with oncology clinical trials and early development clinical trials.
Strong knowledge of Good Clinical Practice (GCP).
Demonstrated operational excellence in managing projects and contributing scientifically.
Skills:
Clinical Monitoring, Clinical Research, Clinical Trial Protocols.
Strong decision-making, drug development, and medical strategy skills.
Excellent communication, interpersonal, and leadership abilities.
Languages:
Proficiency in English.
Why Novartis:
At Novartis, we strive to reimagine medicine to improve and extend people’s lives. Our collaborative, passionate teams are committed to delivering breakthroughs in healthcare. Ready to create a brighter future together? Learn more at Novartis About.
Division: Biomedical Research
Business Unit: Pharma Research
Location: Hyderabad (Office), India
Company: Novartis Healthcare Private Limited
Functional Area: Research & Development
Employment Type: Full time
Shift Work: No
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