Global Medical Affairs Director

Summary

LOCATION: London or Barcelona
ROLE TYPE: Hybrid Working, #LI-Hybrid

The Global Medical Affairs Director develops and implements strategic and operational Therapeutic Areas (TAs) Global Medical Affairs programs.

Focused on innovative evidence and launch readiness along with post-market solutions, including medical affairs planning and execution of the medical/scientific engagement strategy. They address and deliver strategic pre-launch and launch medical activities needs for patient, clinical, access and value to health care systems.

Providing expertise in the development and execution of the overarching strategies and providing inputs during design and along the end-to-end execution of programs. They also develop and execute the Integrated Evidence Plan (IEP)/functional specific programs to maximize the value proposition for the prioritized launch portfolio and impact of our medicines.

About the Role

Key Responsibilities:

The Global Medical Affairs (GMA) team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the TA. They develop/own IEP and provide input into development while ensuring US and International medical perspective is reflected.

Responsible for the implementation of medical strategies for early programs globally with focus on innovative evidence solutions including interventional studies, Non-interventional studies (NIS) and Real World Evidence (RWE) studies and implementation science projects. With extensive experience in drug development the Global Medical Affairs Director will be able to lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. They will also manage the most complex assets and those that potentially will require deeper pharmacovigilance expertise.

Acting 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. They will provide leadership and deep medical expertise in the TA, pivoting support based on business priorities and will represent GMA with senior stakeholders.

Major Accountabilities:

• 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, Medical Science Liaison (MSL) / Field Medical Affairs strategy, innovative medical education programs and scientific communications plans for external stakeholders, scientific publication planning and Medical Expert network development with TAs
• Financial tracking to ensure timely and cost-effective development & execution of medical activities
• Prepare Safety Review Committee (SRC) submissions for TA assets within remit
• Partner with Development, S&G, US and International cross-functions to shape portfolio early and diversify evidence to achieve broad access at launch and to enhance impact on clinical practice for priority programs
• 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
• Provide direction and input into the development and implementation of successful reimbursement and market-access strategies
• Provide proactive input to Development on potential new therapeutic indications, to enrich Registration Programs and to consider new therapeutic opportunities.
• Ensure GMA activities are designed and executed in compliance with company policy guidelines and highest medical quality standards and that Patient Access programs are supported for all brands within the GMA and delivered with full compliance

Essential Requirements:

• Medical Degree (MD) (Preferred) or PhD/PharmD in Health Sciences.
• Specialist Degree or specialist qualification related to cardiovascular medicine (including anticoagulation) and/or pharmaceutical medicine (or its equivalent) is an advantage.
• 5+ years in Pharmaceutical Industry with experience in Medical Affairs at global level and/or Clinical Development
• Deep understanding of health care systems and key external stakeholders
• Critical thinker, agile mindset, ability to navigate uncertainty without major supervision, ability to truly collaborate across functions and markets (serve-partner-co-create) and a strong track record of delivery focus for time and quality in medical affairs projects
• Successful development and implementation of innovative programs and processes
• Understands unmet medical needs, generates the right evidence to fulfil them, uses innovative, multichannel communication formats for effective evidence dissemination
• Credibility as peer expert with external stakeholders; Patient interaction and engagement experience.
• Firm working knowledge of Good Clinical Practice (GCP,) scientific and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authorities.

Preferred Experience

• Highly preferred: Cardiovascular medicine expertise including expertise with anti-coagulant therapy, significant medical affairs early asset lifecycle, pre-launch and launch experience in Global organizations
• Experience in developing and executing “Best in Class” processes at scale
• Clinical trial research experience conducted in a pharmaceutical or equivalent academic environment in cardiovascular medicine is strongly desired.

Why Novartis:
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