105,000 people reimagining medicine for more than 766 million people globally. To provide country clinical strategic guidance and feasibility assessment for GDD trials.
Your responsibilities include, but are not limited to
• To provide clinical strategic and tactical leadership in the country to support GDD trials, clinical development plans which change the world, concept sheets/protocols and other clinical program documents as needed. To provide country clinical strategic guidance and feasibility assessment for GDD trials. Closely collaborates with the Trial Monitoring Organisation and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan
• May lead medical/clinical discussion with local regulatory interactions as needed (CTA, NDA meetings, label discussions, post-approval commitments etc.). Cooperates with local functions such as e.g. Medical Affairs, Patient access to identify and involve qualified investigators with recruitment potential and relevant key experts for clinical development in order to exploit the value of the assigned project(s) in the context of the investigational product(s).
• Provide clinical development and indication expertise specific to a country and drives together with the local TMO organization execution of clinical trials with high quality and in planned timelines: 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 recruitment 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, and other functions in the country as needed, 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 feedback, 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, 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, Review and try to resolve local medical issues / questions and, if feasible, support TMO with recruitment/ operational issues that arise during the entire course of the study - if necessary, support the discussion of issues to global teams. Perform local AE review for development compounds and provide general medical support for safety issues: Provide medical expertise support to pharmacovigilance activities, responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed, follow-up with the Investigator for additional information or clarifications as needed, When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc
• May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as CO representative in Regional/Global team. Identify high quality local/regional datasets (e.g. registries etc) which could be used to drive innovative study designs or support recruitment, Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and local regulations, Participation in Early product planning process to ensure that TMO trials conducted optimize cross-functional CO strategy, Participate in global working groups in order to support and improve processes for the CD&A/CRMA Line function
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
WHAT YOU’LL BRING TO THE ROLE:
• Scientific degree (medical degree highly desirable, ≥ 40 % of CRMA FTEs in a country if possible).
• Trained in relevant aspects of clinical drug development including GCP, local regulatory requirements and data privacy laws.
• Subspecialty training desirable, but not required
• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex clinical / medical / operational issues
• Agility to move fast across different therapeutic areas and indications
• At least 3 Years clinical development experience in pharmaceutical industry
• Sound understanding of the overall clinical development and ICH/GCP
766 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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