Director - Medical Affairs

Summary

The Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area.

Develops / owns IEP and provides input into development while ensuring US and Int'l medical perspective is reflected.

Is responsible for the implementation of medical strategies for early programs globally with focus on innovative evidence solutions including interventional studies, NIS and RWE studies and implementation science projects.

Based on extensive experience in drug development will be able to lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. Will manage the most complex assets and those that potentially will require deeper pharmacovigilance expertise.

Will act as a subject matter expert in the development of the overarching strategies, providing inputs during design and along the end-to-end execution of programs across different disease areas.

Will provide leadership and deep medical expertise in the TA, pivoting support based on business priorities and will represent GMA with senior stakeholders when needed

Acts a strategic partner to NIBR, Development, International Medical Affairs, US MA

Acts as Global Medical Affairs responsible for review of Managed Access Programs (MAPs) Acts as Global Medical Affairs responsible for Post Study Drug Supply (PSDS)

Represent Global Medical Affairs at GPTs and be a strategic partner to life-cycle management of In-Market brands

Responsible for medical information related activities to the Therapeutic Area

About The Role

Director Medical AI & Innovation

Location – Hyderabad Hybrid

About The Role

The Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area.

Develops / owns IEP and provides input into development while ensuring US and Int'l medical perspective is reflected.

Is responsible for the implementation of medical strategies for early programs globally with focus on innovative evidence solutions including interventional studies, NIS and RWE studies and implementation science projects.

Based on extensive experience in drug development will be able to lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. Will manage the most complex assets and those that potentially will require deeper pharmacovigilance expertise.

Will act as a subject matter expert in the development of the overarching strategies, providing inputs during design and along the end-to-end execution of programs across different disease areas.

Will provide leadership and deep medical expertise in the TA, pivoting support based on business priorities and will represent GMA with senior stakeholders when needed

Acts a strategic partner to NIBR, Development, International Medical Affairs, US MA

Acts as Global Medical Affairs responsible for review of Managed Access Programs (MAPs) Acts as Global Medical Affairs responsible for Post Study Drug Supply (PSDS)

Represent Global Medical Affairs at GPTs and be a strategic partner to life-cycle management of In-Market brands

Responsible for medical information related activities to the Therapeutic Area

Key Responsibilities

• Lead development and execution of medical affairs strategy for TA / 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 TAs
• Represent GMA around prioritized portfolio with internal and external audiences, in collaboration with TAs including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators / partners
• To review a new MAP request within two working days, following receipt of all required information.
• Create MAP treatment strategy worldwide plan for compounds and seek leadership endorsement, in co- ordination with line functions including program safety
• Development of patient consent / assent, product form, baseline / follow-up questions, Statistical Analysis Publication Plan (MSAPP) & other relevant activities, as applicable
• Develop PSDS cover letter to highlight any new or additional compound-specific information for the physician (e.g. relevant risk minimization materials)
• Review the PSDS Treatment Plan and the PSDS-specific patient consent requirements on an ongoing basis (at a minimum annually) for any relevant updates and liaise with global safety regulatory and other relevant line functions, as needed

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Essential Requirements

Desirable Requirements

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

Commitment To Diversity And Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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.

Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together https : / / www.novartis.com / about / strategy / people-and-culture

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Benefits and Rewards : Read our handbook to learn about all the ways we'll help you thrive personally and professionally : https : / / www.novartis.com / careers / benefits-rewards

Skills Required

Gcp, Pharmacovigilance, clinical development, Regulatory Requirements, Medical Affairs