About the Role:
The role is to provide clinical strategic and tactical leadership to support GDD trials, clinical development plans which change the world, concept sheets/protocols and other clinical documents. This role also responsible to provide country clinical strategic guidance and feasibility assessment for NIBR PoC trials, closely collaborates with the Trial Monitoring Organization and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification.
Key Responsibilities :-
• Closely collaborates with the Trial Monitoring Organisation to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruit- ment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
• Provides robust indication and protocol training to CRAs and CSEs
• Provide protocol, Risk management plan & disease training as appropriate, and externally at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed- back, etc.) and analysis of the competitive environment
• Provide medical/clinical assistance to TMO and site for IEC/IRB Interactions
• Review country or site specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to Development clinical trials /NIBR PoC studies when translated into the local language, including the patient narrative where appropriate
• Support Ministry of Health interaction (or local Board of Health) as required. Perform local AE review for development compounds and provide general medical support for safety issues.
• Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical/clinical input as appropriate as this relates to global development clinical trials and NIBR PoC trials. Support planning, implementation and follow-up of regulatory agency inspections and internal audits
Essential Requirements
• A degree or equivalent experience in scientific or health subject area required
• At least 3 Years clinical development experience in pharmaceutical industry
• Understanding of the overall clinical development and ICH/GCP
• Ability to handle a study from the medical/clinical perspective, and a proven capability to problem tackle and mediate sophisticated- clinical / medical / operational issues
• Agility to move fast across different therapeutic areas and indications
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
