Summary

Medical expert for TCO (Translational Clinical Oncology) trials. Provides global medical leadership for TCO wind down studies and global co-leadership for active TCO studies when appropriate.

About the Role

Major accountabilities:

• Provides scientific and medical expertise on assigned clinical projects
• Contributes to clinical strategy for the Asian region
• Accountable for all aspects related to wind down projects including review of clinical data, and oversight of all CSR related activities
• Contributes to clinical trial data medical/scientific review for assigned TCO projects and coordinates data analysis and interpretation including the development of first interpretable results, clinical study report, publications, and internal/external presentations.
• Builds and maintains high performance cross functional teams in TCO and with partners
• Manages stakeholder engagements internally and externally
• Mentors and coaches junior TCO team members
• Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Leads or assists with relevant trainings across TCO India
• Advocate continuous improvement of quality
• Ensure all activities of associates comply with company standards and local regulations

• Management of assigned studies to ensure execution according to timelines, budget and with high quality, ensuring adherence to international and local regulations.
• Demonstrates excellent scientific writing skills to enable the development of quality trial reporting, and regulatory documents.
• Effective risk management in design of synopses, operational planning, and clinical execution.
• Contribution towards objectives set for the department.
• Feedback from external and internal customers.
• Adherence to Novartis Values and Behaviors.

• >5 years of pharmaceutical/biotech industry experience
• Experience with oncology trials
• Experience with early development trials
• Knowledge of Good Clinical Practice (GCP).
• Strong operational project and management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
• Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects.
• Strategic thinking: ability to network with and influence opinion leaders, clear and logical presentation of complex strategic issues.
• Clear written and verbal expression of ideas, an active/proactive communicator.
• Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships.
• Used to working independently and in a team, being flexible and adapting in a changing environment.

• Fluent oral and written English