L. Kathleen Maley

About L. Kathleen Maley

Accomplished in both molecular biology and cell biology with a proven record in cloning…

Experience

1. Scientific Leadership & Research Manager

   Merck

   May 2016 — Present · Upper Gwynedd, PA, US

   Project manager for Investigator Initiated Studies program including focus on Oncology, Immunology, HIV, and Women’s Health programs to ensure review, regulatory documentation, drug supply, and milestone payments are executed in accordance with tight deadlines and compliance requirements. • Responsibilities include management of over 89 simultaneous clinical and pre-clinical studies and complete budget totals in excess of $40 million.• Manage and coordinate execution of executive engagements with external experts to pressure test and inform strategy, resulting in key actionable recommendations by driving logistic, budget, legal and content concerns and development in compliance with global and local laws and internal processes.• Subject Matter Expert -Asia Pacific Region, in Scientific Leader Engagement, study related regulatory issues, and cross functional process

Education

• The George Washington University

  BA, Biology

  1990 — 1994

• Lehigh University

  MS, Molecular Biology

  2001 — 2006

• Drexel University

  Master of Business Administration - MBA, Finance and Data Analytics

  2018 — 2020

Skills

• Cell
• In Vitro
• Neuroscience
• Western Blotting
• Molecular Biology
• Lifesciences
• Purification
• Protein Chemistry
• Biotechnology
• Laboratory
• Drug Development
• Biopharmaceuticals
• Elisa
• Biochemistry
• High Throughput Screening
• Biomarker Discovery
• Assay Development
• Computer System Validation
• Recombinant Dna Technology
• Pharmacology
• Cell Culture
• Gmp
• Life Sciences
• Pharmaceutical Industry
• Sop
• Biomarkers
• In Vivo
• Glp
• Cell Biology
• Drug Discovery