MEDICAL DIRECTOR, RENAL

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 About the Role Major Accountabilites.
• Lead development and execution of medical affairs strategy for Renal 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 • Co-own the development and implementation of innovative education and scientific communication plans for external stakeholders • Financial tracking to ensure timely and cost-effective development & execution of medical activities • Prepare 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 • Represent “the voice of the patient” internally and evaluate factors relevant to a patient’s informed decision making • 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 that Patient Access programs are supported for all brands within the GMA and delivered with full compliance • Ensures GMA activities are designed and executed in compliance with company policy guidelines and highest medical quality standards • Provide proactive medical input to asset lifecycle management to consider new therapeutic opportunities • Ensure that Patient Access programs are supported for all brands within International Medical Affairs and delivered with full compliance Requirements.
Must have.
• 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.
• 5+ years in Pharmaceutical Industry experience in Medical Affairs and/or Clinical Development • Critical thinker and with ability to navigate uncertainty without major supervision • Fluent oral and written English; Other relevant languages are an advantage.
• Strategic mindset and 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 • Deep understanding of health care systems and key external stakeholders • 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 • Agile mindset & ability to lead in an agile organization across Disease Areas • Firm working knowledge of GCP, scientific and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authorities.
Preferred • Highly preferred.
Renal experience particularly IgA Nephropathy, significant medical affairs early asset lifecycle, pre-launch and launch experience in Global organizations • Rare disease 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