Director - Medical Affairs

Job Description 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

Job Description

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}