James Jim Andahazy

About James Jim Andahazy

I am a SME in pharmaceutical R&D strategy and operations / operational excellence with 20 years in the life sciences, along with a Master of Business and Science, concentration in Drug Discovery and Development. Relevant highlights include:• Proven team leader with exceptional executive presence. • Strong business acumen and experience that bridges science and business.• Passionate people leader, who takes pride in developing and coaching talent.• Demonstrated flexibility to meet the needs of any new challenge or stakeholder.Key skills & competencies include:Communications • Clinical / Regulatory Operations • GCP Quality and Compliance • Program/Project Management • Executive Presentations & Meeting Management • Microsoft (Word, Powerpoint, Excel) • LEAN Six Sigma Green Belt • Operational Excellence / Continuous Improvement • Metrics Development & Monitoring • 7 yrs clinical laboratory operations• 2 years biotech sales and marketing• 9 years pharma business strategy & operations / operational excellence• 3 years GCP quality and complianceResults-oriented leader with significant experience executing multi-year change initiatives including design and implementation of new technology solutions, & transformation and change management efforts resulting in process efficiencies, increases in performance, improvements to quality and compliance, and significant cost savings/avoidance.

Experience

1. Development Business Operations Lead

   Genmab

   Feb 2024 — Present · Princeton, NJ, US

   Business Operations lead supporting key Clinical & Development Operations functions as a thought leader for key strategic decisions. Partner with leadership and enabling functions (HR, finance, quality, strategic initiatives) to provide sound financial oversight, identification of key staffing / resourcing needs, and support a culture of continuous improvement.• Provide strategic insights and guidance as a leadership team member, ensuring the functional team is structured to support evolving business needs.• Manage clinical trial operations resource allocations, forecasting & demand, leveraging data to justify headcount requests and build business cases for new capabilities.• Led process improvement initiatives, including: o Facilitating workshops to enhance the protocol development process, reducing cycle times and rework. o Project managing the design and implementation of a principles-based framework for clinical/regulatory document development.As an AI champion, leveraging Chat GPT and sharing learnings to save time on administrative tasks, to evaluate contracts and other complex documents, and to develop business cases in the support of organizational restucture and to define resourcing needs.

Education

• Rutgers University

  Master of Business and Science (MBS), Drug Discovery and Development

  2015

• Villanova University

  Bachelor of Science, Comprehensive Science Program

  1998 — 2002

Skills

• Clinical Development
• Pharmaceutical Industry
• Sop
• Glp
• Genetics
• Flow Cytometry
• Pcr
• Drug Discovery
• Clinical Trials
• Elisa
• Clinical Research
• Cell
• Laboratory
• Drug Development
• Biotechnology
• Immunology
• Life Sciences
• Immunoassays
• Rt-Pcr
• Lifesciences
• Oncology
• Science