Job
Description
As the Director Medical AI & Innovation at Novartis, you will be a key member of the Global Medical Affairs team, leading the medical strategy for the therapeutic area. Your role will involve developing and owning Integrated Evidence Plans (IEPs), providing input into development processes, and ensuring that both US and international medical perspectives are reflected. You will be responsible for implementing medical strategies for early programs globally, focusing on innovative evidence solutions such as interventional studies, Non-Interventional Studies (NIS), Real-World Evidence (RWE) studies, and implementation science projects. Your extensive experience in drug development will enable you to lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. You will manage the most complex assets, including those requiring deeper pharmacovigilance expertise. Acting as a subject matter expert, you will contribute to the development of overarching strategies, provide inputs during program design, and oversee end-to-end execution across different disease areas. Key Responsibilities: - Lead the development and execution of medical affairs strategy for therapeutic area/asset priority programs, including transformative tactics such as research/population health, innovative partnerships, and integrated evidence plans. - Co-develop plans for evidence generation, MSL/Field Medical Affairs strategy, medical education programs, scientific publication planning, and Medical Expert network development with Therapeutic Areas. - Represent Global Medical Affairs around the prioritized portfolio with internal and external audiences, collaborating with Therapeutic Areas, investment, medical, and regulatory communities, as well as industry collaborators/partners. - Review Managed Access Program (MAP) requests promptly and create MAP treatment strategy worldwide plans for compounds, seeking leadership endorsement in coordination with line functions. - Develop Post Study Drug Supply (PSDS) cover letters and treatment plans, ensuring alignment with patient consent requirements and liaising with global safety regulatory functions as needed. Qualifications Required: - MD (Preferred) or PhD/PharmD in Health Sciences. Specialist Degree or specialist qualification related to the responsible discipline is advantageous. - Minimum of 10 years of experience in the Pharmaceutical Industry in Medical Affairs and/or Clinical Development. - Critical thinker with the ability to navigate uncertainty independently. - Fluent in oral and written English; proficiency in other relevant languages is beneficial. - Strong credibility and influencing skills across diverse stakeholders in a matrix organization to drive change. - Collaboration skills to work across functions and markets, serving as a partner in co-creation efforts. - In-depth knowledge of Good Clinical Practice (GCP), scientific and clinical methodology, protocol designs, and regulatory requirements for clinical studies. By joining Novartis, you will be part of a team committed to reimagining medicine to improve and extend people's lives. Learn more about our mission and vision at: [Novartis Mission and Vision](https://www.novartis.com/about/strategy/people-and-culture). For more details on benefits and rewards, refer to the [Novartis Life Handbook](https://www.novartis.com/careers/benefits-rewards). Novartis is dedicated to fostering an inclusive work environment and diverse teams that reflect the patients and communities we serve. If you require accommodation due to a medical condition or disability during the recruitment process, please contact us at [email protected] with your request and contact information, mentioning the job requisition number. Join us at Novartis and be part of a community of smart, passionate individuals working together to achieve breakthroughs that change patients" lives. Explore career opportunities and stay connected by joining the [Novartis Network](https://talentnetwork.novartis.com/network).,
