Global Medical Affairs Director, Autoimmune Diseases

Role Summary

The Global Medical Affairs Director develops and implements strategic and operational Therapeutic Areas (TAs) Global Medical Affairs programs. Location: London, Barcelona, Basel (East Hanover). Role Type: Hybrid Working. 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.

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 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.

Qualifications

• Medical Degree (MD)
• Specialist Degree or specialist qualification related to Rheumatology.
• 5+ years in Pharmaceutical Industry with experience in Medical Affairs at global level and/or Clinical Development
• Firm 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 authorities
• 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.