Gene E. Schulze

About Gene E. Schulze

Dr. Schulze is a pharmaceutical executive and scientist with an impeccable record of success in delivering new drugs, biotherapeutics, and medical devices to the marketplace by enabling human clinical trials through innovative and scientifically-driven safety assessments. He has worked for and with some of the premiere scientific institutes and pharmaceutical, medical device, and contract research companies. His broad depth of experience and scientific knowledge in toxicological sciences and pharmaceutical development has resulted in a record replete with achievements at every step. Dr. Schulze is a scientific leader, whose work has contributed to the successful development of life-altering medical treatments.Dr. Schulze rejoined Bristol-Myers Squibb Company to support safety evaluations of new drug and biologic medicines after spending time as principal of GES Consulting offering preeminent product development and toxicology consulting services. Previously, as an Executive with the Alcon Laboratories and Bristol-Myers Squibb, Dr. Schulze led and managed teams (of 55 to 100+) that designed, executed, interpreted, and filed safety evaluations in support of new drug, biologic, or medical device regulatory or marketing applications. These non-clinical safety evaluations were conducted to the highest scientific and regulatory standards. Dr Schulze is an expert in non-clinical drug development with particular expertise in CNS, Oncology and Immunology, and Ophthalmology therapeutic areas. Specialties: Pharmaceutical Drug Development – 20 years; Toxicology and Laboratory Management -15 years; Biologic’s Development - 15 years Scientific management -15 years; Toxicology expertise -25 years.

Experience

1. Executive Director, Nonclinical Safety

   Assembly Biosciences, Inc.

   Feb 2022 — Present · South San Francisco, CA, US

Education

• University of Kentucky

  Master's degree, Toxicology

  1981 — 1982

• University of Kentucky

  Doctor of Philosophy (Ph.D.), Toxicology

  1982 — 1985

• University of Kentucky

  Bachelor's degree, Microbiology

  1978 — 1981

Skills

• CRO
• Toxicology
• Oncology
• Protocol
• Biomarkers
• Therapeutic Areas
• Pharmacology
• Life Sciences
• Pharmaceutical Industry
• Fda
• Medical Devices
• Clinical Research
• Regulatory Affairs
• Lifesciences
• Regulatory Submissions
• Glp
• Hplc
• Clinical Development
• Immunology
• Laboratory
• Drug Development
• Biotechnology
• 21 Cfr Part 11
• Pharmaceutics
• Drug Discovery
• Regulatory Requirements
• Ind
• Clinical Trials