Zbigniew Christopher Kosman
Houston,TX
Summary
Seasoned Independent Consultant with a robust background in pharmacology and toxicology, honed at companies like Merck. Expert in regulatory compliance and fostering teamwork, I excel in developing preclinical strategies and safety assessments. Proven track record in enhancing drug development processes through innovative problem-solving and effective communication.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Independent consultant
Drug Safety Consulting, LLC
Houston, USA
01.2010 - Current
- Regulatory and development of preclinical development strategy
- Writing SOPs and training material, CROs audits
- Toxicologist/study monitor
- Writing study proposals, editing protocols and reports review (toxicology, safety pharmacology)
- Cardiology consultant, review ECG and cardiovascular data, development of animal model
Consultant, Pharmacology and Toxicology
Envol Biomedical
New York, USA
03.2020 - 04.2021
- VP
- Pharmacology and Toxicology (full time contract, on site)
- General toxicology, safety pharmacology and behavioral/neurological assessment, animal model development and regulatory
- Responsible for writing study proposals, protocols, and reports
- Small and large molecules and devices
Senior Scientist/Study Director
Sinclair Research Institute
Columbia, USA
01.2016 - 01.2017
- Study Director, general toxicology, and safety pharmacology studies
- Developed and validated the safety pharmacology program (core battery) and several animal models for drug development studies such a: seizures, emesis/nausea, depression liabilities, GI, renal safety, cardiotoxicity, and tier II CNS
Senior Scientist, Toxicology and Regulatory Affairs
NexBio Inc.
San Diego, USA
01.2010 - 01.2011
- Regulatory toxicologist, study monitor (outsourced studies), general and inhalation toxicology studies (non GLP and GLP) and regulatory toxicologist
- Reviewed preclinical safety section of IND submissions
- Assisted defining pre-clinical safety plans based on regulatory and clinical development requirements
- Responsible for CROs evaluation, writing study proposals, review protocol and reports
- Prepared non-clinical budgets
- Developed several animal models for drug discovery and development
Senior Scientist, Study Director
Ricerca Biosciences Inc.
Concord, USA
01.2009 - 01.2010
- Company Overview: (CRO)
- General toxicology and safety pharmacology studies (GLP and non-GLP)
- Small and large molecules and devices
- Developed the safety pharmacology program (core battery) and several animal models for drug development studies
- (CRO)
Principal Scientist III, Drug Development
Encysive Pharmaceuticals Inc.
Houston, USA
01.2005 - 01.2008
- Recommended strategies for Clinical Drug Development Dept
- And IRB to assure adherence of pre-clinical studies and clinical studies
- Accountable for development, execution, and regulatory submissions of all drug safety project plans with direct involvement and oversight of all outsourced safety pharmacology and toxicology (acute, subchronic, reproductive, genotoxic, carcinogenicity) studies, analytical assay development and validation for dose formulation and non-clinical and human bioanalysis, in-vivo and in-vitro ADME
- Evaluated, selected, and monitored a contract research organization (CROs) and to ensure compliance with good laboratory practice (GLP) and international committee of harmonization (ICH) guidelines
- Developed/validated animal models for five drug discovery groups
- Scheduled and tracked project-specific and operational activities
- Collaborated with QA and provided regulatory expertise and policy support for GLP
- Prepared/reviewed Regulatory Standard Operating Procedures
- Drafted Investor Brochures
Senior Scientist, Study Director
Perry Scientific, Inc.
San Diego, USA
01.2004 - 01.2005
- Company Overview: (CRO)
- General toxicology (GLP and non-GLP), DMPK, TK and efficacy studies
- Devices, small and large molecule studies
- (CRO)
Principal Scientist II, Investigative Toxicology and Safety Pharmacology
Merck
San Diego, USA
01.1999 - 01.2004
- Company Overview: (MRL San Diego)
- Accountable for development and execution of investigative toxicology, TK, safety pharmacology (core battery), and oversight of all outsourced safety pharmacology and toxicology studies
- Developed safety pharmacology (cardiovascular and CNS) program in San Diego site
- Inspected and selected CROs, developed study proposals, reviewed and edited the study protocols and reports
- Study monitor
- Regulatory Toxicologist
- Drafted and edited non-clinical safety assessment tables for IND application (2000-2004)
- (MRL San Diego)
Principal Scientist I, Investigative Safety Pharmacology
AstraZeneca
Wilmington, USA
01.1998 - 01.1999
- Conducted the core battery (cardiovascular, CNS, respiratory) and acute toxicity studies
Postgraduate Research Fellow
University of Pennsylvania
Philadelphia, USA
01.1995 - 01.1998
- Emphysema research
- Multi-departmental grant
- Planning and coordination of in vivo studies
- Accountable for thoracic surgery, anesthesia, physiological monitoring, immunohistopathology, data collection, analysis, and presentation
Education
DVM -
School of Veterinary Medicine
Warsaw, PolandMS - Pharmacology/Toxicology
Thomas Jefferson University
PhiladelphiaRegulatory Affairs Certificate -
UCSD
San DiegoComparative Medicine -
University of Pennsylvania
Clinical Drug Development Process -
Quintiles Global Learning and Development Training Program
Skills
- Regulatory compliance
- Effective communication
- Problem-solving abilities
- Problem-solving aptitude
- Teamwork and collaboration
- Task prioritization
Phone
cell, 8586108332
Certification
Certified RAC
Timeline
Consultant, Pharmacology and Toxicology
Envol Biomedical
03.2020 - 04.2021
Senior Scientist/Study Director
Sinclair Research Institute
01.2016 - 01.2017
Independent consultant
Drug Safety Consulting, LLC
01.2010 - Current
Senior Scientist, Toxicology and Regulatory Affairs
NexBio Inc.
01.2010 - 01.2011
Senior Scientist, Study Director
Ricerca Biosciences Inc.
01.2009 - 01.2010
Principal Scientist III, Drug Development
Encysive Pharmaceuticals Inc.
01.2005 - 01.2008
Senior Scientist, Study Director
Perry Scientific, Inc.
01.2004 - 01.2005
Principal Scientist II, Investigative Toxicology and Safety Pharmacology
Merck
01.1999 - 01.2004
Principal Scientist I, Investigative Safety Pharmacology
AstraZeneca
01.1998 - 01.1999
Postgraduate Research Fellow
University of Pennsylvania
01.1995 - 01.1998
Certified RAC
DVM -
School of Veterinary Medicine
MS - Pharmacology/Toxicology
Thomas Jefferson University
Regulatory Affairs Certificate -
UCSD
Comparative Medicine -
University of Pennsylvania
Clinical Drug Development Process -
Quintiles Global Learning and Development Training Program
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