Overview
Global Medical Affairs Director, Autoimmune Diseases – Novartis
Location : London, Barcelona, Basel on East Hanover. Role type : Hybrid Working.
About the Role
The Global Medical Affairs Director develops and implements strategic and operational Therapeutic Areas (TAs) Global Medical Affairs programs. This role focuses on innovative evidence and launch readiness, post-market solutions, medical affairs planning and execution of the medical / scientific engagement strategy. They address and deliver strategic pre-launch and launch medical activities to support patients, clinical programs, access, and value to health care systems. They develop and execute Integrated Evidence Plans (IEP) and functional programs to maximize the value proposition for the prioritized launch portfolio and impact of our medicines. They provide leadership and medical expertise across disease areas and represent GMA with senior stakeholders.
Key Responsibilities
- Lead medical–scientific input for Global Medical Affairs studies : evidence gap and competitor analyses; study planning, execution and reporting; authoring study documents (concepts, protocols, SAP / DAP, CRFs, reports, publications); advisory board and training materials; ongoing medical review and interpretation (Phase IIIB–IV, PMS, NIS, RWE); act as key medical contact.
- Serve as a disease-area medical and scientific expert for internal stakeholders (PMAT, GCT, ISRC, Research, Device, Marketing, Patient Access, Country Organisations) and external stakeholders (HCPs, PAGs).
- Co-develop Brand / Franchise Medical Affairs strategy and plan; shape programme / brand publication plans with Scientific Communications; provide medical leadership to new product and pipeline activities.
- Lead and support evidence generation across RWE and HEOR in collaboration with RWE / HEOR leaders and Country Medical teams.
- Provide medical input and support for education and communications : speaker training, medical expert engagement, pre- / launch activities; create and review scientific materials in partnership with Scientific Communications.
- Enable Global Field Medical Excellence : supply up-to-date content and training for MSLs and Country Medical Affairs; support implementation of key Field Medical processes and discuss outcomes to drive actions; develop content for digital tools.
- Provide medical input across programme deliverables : Medical Affairs sections of IDP / CDP; support regions / countries on local Medical Affairs clinical programmes and pre-launch; value dossiers and payer advisory participation; global guidance and NEETs; review publications; input to PSURs / DSURs.
- Ensure medical accuracy, compliance and approvals for promotional and non-promotional global materials; deputise for the Executive Medical Director across PMAT / GCT / GPT, regional alignment, internal decision boards and external activities.
Essential Requirements
Medical Degree (MD)Specialist Degree or specialist qualification related to Rheumatology5+ years in Pharmaceutical Industry with experience in Medical Affairs at global level and / or Clinical DevelopmentFirm working knowledge of Clinical Trials, including Good Clinical Practice (GCP), scientific and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authoritiesDeep understanding of health care systems and key external stakeholdersCritical thinker with agile mindset, ability to navigate uncertainty without major supervision, collaborative across functions and markets, and a strong track record of delivery for time and quality in medical affairs projectsSuccessful development and implementation of innovative programs and processesUnderstands unmet medical needs, generates the right evidence to fulfil them, uses innovative, multichannel communication formats for effective evidence disseminationCredibility as peer expert with external stakeholders; patient interaction and engagement experienceWhy Novartis
Our purpose is to reimagine medicine to improve and extend people’s lives. Be a part of this mission and join us. Learn more here :
You’ll Receive
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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.
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Seniority level
DirectorEmployment type
Full-timeJob function
Health Care ProviderIndustries : Pharmaceutical Manufacturing#J-18808-Ljbffr