Scientific & Clinical Study Manager

3 days ago

London, United Kingdom Novartis Farmacéutica Full time

The Global Medical Affairs team acts as the 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 a focus on innovative evidence solutions including interventional studies, NIS, 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 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 as a strategic partner to NIBR, Development, International Medical Affairs, and US MA. 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.
• 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.
• 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.
MD (Preferred) or PhD/PharmD in Health Sciences. 5+ years in Pharmaceutical Industry experience in Medical Affairs and/or Clinical Development.
• Critical thinker with the ability to navigate uncertainty without major supervision.
• Fluent oral and written English; Other relevant languages are an advantage.
• 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, and uses innovative, multichannel communication formats for effective evidence dissemination.
• 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.
Renal experience particularly IgA Nephropathy, significant medical affairs early asset lifecycle, pre-launch, and launch experience in Global organizations.
• Clinical trial research experience conducted in a pharmaceutical or equivalent academic environment in TA of interest is strongly desired.
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. 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.
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
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