▷ [Only 24h Left] 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 Director Medical AI Innovation Location - Hyderabad LI 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 MD Preferred or PhD PharmD in Health Sciences Specialist Degree or specialist qualification related to discipline for which you will be responsible is an advantage At least 10 years in Pharmaceutical Industry experience in Medical Affairs and or Clinical Development Critical thinker and with ability to navigate uncertainty with major supervision Fluent oral and written English Other relevant languages are an advantage Able to establish credibility and influence across a range of diverse stakeholders in a matrix organization to drive change Ability to truly collaborate across functions and markets serve-partner-co-create Able to navigate in an environment of shared outcomes and cross-business accountabilities Firm working knowledge of GCP scientific and clinical methodology protocol designs management and regulatory requirements for clinical studies designated for review by regulatory authorities Desirable Requirements Highly preferred TA expertise significant medical affairs early asset lifecycle pre-launch and launch experience Experience in developing and executing Best in Class processes at scale Clinical trial research experience conducted in a pharmaceutical or equivalent academic environment in TA of interest is strongly desired 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 Skills Desired Agility Agility Clinical Practices Cross-Functional Collaboration Data Analysis Drug Development Employee Development Healthcare Sector Understanding Health Sciences Influencing Skills Innovation Inspirational Leadership Integrated Evidence Generation Medical Affairs Medical Communication Medical Education Patient Care People Management Pharmaceutics Priority Disease Areas Expertise Product Launches Product Strategy Real World Evidence RWE Regulatory Compliance Research Methodologies 4 more