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Omer Kaya
Director, Program Lead @Viatris
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WORK HISTORY
Director, Program Lead @Viatris
Dublin, IE
Program Leadership: Direct end-to-end program management for a portfolio of complex drug-device combination products. Lead cross-functional teams to deliver integrated development and commercialization strategies.· Strategic Planning & Execution: Spearhead strategic and operational planning, including goal setting, budget forecasting, resource planning, and scenario analysis. Develop and execute integrated program plans that align with corporate business objectives, ensuring delivery within scope, budget, and timeline constraints.· Driving Regulatory Submissions & Product Lifecycle: Orchestrate and deliver successful regulatory submissions across major international markets. Lead lifecycle management activities from early-stage development through technology transfer, commercial launch, and post-market remediation.· Risk & Stakeholder Management: Proactively identify, communicate, and mitigate program risks to executive leadership and global stakeholders. Provide strategic guidance to internal and external teams to ensure alignment and successful execution of program goals.
EDUCATION
Orta Doğu Teknik Üniversitesi / Middle East Technical University
3,01
Orta Doğu Teknik Üniversitesi / Middle East Technical University
3,29
SKILLS
ABOUT OMER KAYA
Accomplished pharmaceutical leader with over 20 years of progressive experience in Program Management, Technical Operations, and Quality. I specialize in leading the end-to-end development and launch of complex drug-device combination products, strategy development and execution, translating scientific innovation into robust, market-ready therapies.My expertise lies in orchestrating global, cross-functional teams to deliver on strategic objectives: navigating complex regulatory pathways (US, EU, UK), managing technology transfers to CMOs, and steering programs from early-stage development through successful commercial launch and lifecycle management. I have a proven track record of building high-performing teams, optimizing operational processes, and driving strategic initiatives and continuous improvement through structured methodologies.Core Competencies:· Program & Portfolio Leadership · Pharmaceuticals and Combination Product Development· Cross-Functional Team Leadership & Strategy· Regulatory Submissions & Lifecycle Management· Technology Transfer & Scale-Up in Biologics and OSD· Quality Management & Operational Excellence· Budget & Resource Management
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