SENIOR SCIENTIFIC INVESTIGATOR/ SENIOR MANAGER/TOXICOLOGIST, GENERAL TOXICOLOGY
Microsoft Word, Excel, and PowerPoint; Adobe Acrobat; Documentum; Instem Provantis®
Bachelor of Science: BiologyUniversity of IllinoisChampaign, CERTIFICATIONSBiology Diplomate, American Board of Toxicology
Integration of New Drug Development Tools into the FDA Regulatory Framework Regulatory Affairs Certificate: Pharmaceuticals Courses - RAPS Online University Effective Responses to FDA Enforcement: Actions in a Risk-Based Environment IND Soup to Nuts - IND Format and Content, the IND Process, Conducting Clinical Trials, and Maintaining the IND Drug Development and FDA Regulations: A Regulatory Overview Preparing for and Facilitating Key FDA Meetings Evaluation of Cardiac Drug Toxicity in Pharmaceutical Discovery and Development Drug Discovery and Development Simulation: Candidate Selection to Launch Impurities: Assessing Safety Risk and Managing Regulatory Impact Due Diligence Training Course Challenges in Development of Anticancer Drugs Pharmacokinetic Applications in Drug Development University of North Carolina School of Pharmacy
Master of Science: Biological SciencesSouthern Illinois University at CarbondaleBiological Sciences
Scientific Thinking and Writing
Senior Scientific Investigator/ Senior Manager/Toxicologist, General Toxicology01/1993 to CurrentGlaxoSmithKlineResearch Triangle Park, NC
Prepared protocols, final reports, regulatory documents (e.g., INDs, investigator brochures, and tabulated summaries), study documentation, and standard operating procedures to support US and international regulatory submissions for small molecules and biologics in a number of therapeutic areas (including infectious diseases, metabolic, oncology, cardiovascular, and dermal).
Created posters, manuscripts, presentations, global guidelines for General Toxicology report writing, training manuals, and harmonized templates for reports and protocols (both in-house and in collaboration with contract research organizations).
Peer reviewed numerous nonclinical reports, presentations, manuscripts, and regulatory documents such as investigator brochures, INDs, and tabulated summaries.
Performed literature searches to answer regulatory questions, investigate new toxicities, or enhance study designs.
Acted as preclinical safety representative on drug development teams for multiple therapeutic areas.
As study director designed, initiated, conducted, monitored, and interpreted data and statistical analysis results for in-house preclinical drug safety assessment studies conducted according to Good Laboratory Practice regulations.
Supervised and monitored studies conducted at contract toxicology laboratories for conformance with various US and international regulations.
Managed study directors, study toxicologists, editors, and scientific writers.
Provided strategic planning and oversight of study scheduling, including scheduling General Toxicology study director resources, resolving timeline conflicts, and reallocating resources based on changes in project priorities.
Toxicologist/Study Director, Toxicology Department01/1991 to 01/1993Utah Biomedical Test LaboratorySalt Lake City, UT
Responsible for study design, protocol preparation, cost estimates, study schedules, monitoring technical aspects of studies, development of standard operating procedures, preparation of reports, and interaction with clients to discuss study requirements and study progress.
Study Coordinator/Research Associate01/1987 to 01/1991Hazleton Wisconsin, IncMadison, WI
Responsibilities included interacting with clients; scheduling studies; preparing protocols; monitoring study progress; compiling, reviewing, and summarizing data; writing interim and final reports; and preparing cost estimates.
Supervised scientific writers, data tabulation/statistical analysis personnel, and administrative staff.
Manager, Acute Toxicology/Toxicology Technician01/1982 to 01/1987American Biogenics Corporation/Whitaker ToxiGenics, IncDecatur, IL
Served as study director and supervisor of technical staff.
Interfaced with clients to determine study design and communicate study results, developed and wrote experimental protocols and Standard Operating Procedures, oversaw conduct of studies, interpreted study data, and wrote final reports.
Chandra SA, Stokes AH, Hailey R, Merrill CL, Melich DH, DeSmet K, Furst SM, Peterson RA, Mellon-Kusibab K, Adler RR. Dermal Toxicity Studies: Factors Impacting Study Interpretation and Outcome. Toxicol Pathol. 2014 Nov 10. Chandra SA, Peterson RA, Melich D, Merrill CM, Bailey D, Mellon-Kusibab K, Adler R. Dermal Irritation of Petrolatum in Rabbits but not in Mice, Rats or Minipigs. J Appl Toxicol. 2014 Aug;34(8):857-61. Brown HR, Mellon-Kusibab K, Bertram R, Tillman T, Arrington-Brown L, Jordan H, Gates L, Miller RT.Brief Communication: Intraperitoneal Galactosamine Misdosing as a Possible Interpretation for Responder/Nonresponder Phenotypes. Toxicol Pathol. 2014;42(3):622-625. Tippin TK, Hamilton G, Moore L, Beaudet EJ, Jolley S, Brodie TA, Andrews RC, Becherer JD, McDougald DL, Gaul MD, Hoivik DJ, Mellon-Kusibab K, Lehmann J, Kliewer S, Novick S, Laethem R, Zhao Z, LeCluyse EL. CYP3A Induction by N-Hydroxyformamide Tumor Necrosis Factor- Converting Enzyme/Matrix Metalloproteinase Inhibitors: Use of a Pregnane X Receptor Activation Assay and Primary Hepatocyte Culture for Assessing Induction Potential in Humans. Drug Metabolism and Disposition 31:870-877. PRESENTATIONS Mellon-Kusibab, K. Drug-Induced Liver Fibrosis - Testing Nevirapine in a Viral-Like Liver Setting. A Time-Course Experiment in Brown Norway Rats. PTS DISCovery Science Forum, GlaxoSmithKline, November 21, 2014. Mellon-Kusibab KA, Perkins DG, Tyler R, Brouwer KR, Serabjit-Singh CJ, and Boehlert C. One-Month Oral Gavage Toxicity Study with GF120918 in Beagle Dogs. Abstracts for the 21st Annual Meeting of the American College of Toxicology November 12-15, 2000 San Diego, California, USA. International Journal of Toxicology. November 2000 19: 1-37 Mellon-Kusibab K, Natvig B, Hoivik D, McKinney D, and Dillberger J. Labrafil: Effect of Oral Administration to Han Wistar Rats for a Period of 6 Months. Poster Session, 1998 Annual Group Development Operations US Symposium, Girolami Research Center, Glaxo Wellcome Inc. Mellon-Kusibab K, Hoivik D, Allen D, Brodie T, Tippin T. Screening New Compounds for Toxicological Effects during the Drug Discovery Process. Poster Session, Discovery Day, Glaxo Wellcome Inc., September 9, 1998. Brouwer, KR, Perkins, D, Kerr B, Roberts, PA, Mellon-Kusibab, K, and Wissel, P. Pre-Clinical Guidance for Phase I Trials with MDR Modulators and Chemotherapy: The Effect of GF120918 (GW918) on the Pharmacokinetics and Pharmacodynamics of Doxorubicin. Proceedings of the American Association for Cancer Research Annual Meeting 37 (0). 1996. 375. Boehlert C, Mellon-Kusibab KA, Tyler R, and Serabjit-Singh CJ. Effect of Inducers on Hepatic Tissue from Male and Female Beagle Dogs. Poster Session, Society of Toxicology 34th Annual Meeting, March 1995.
Society of Toxicology
North Carolina Society of Toxicology
North Carolina Society of Quality Assurance
administrative, Adobe Acrobat, brochures, COMPUTER APPLICATIONS, Content, clients, documentation, Documentum, Due Diligence, Good Laboratory Practice, IND, director, Managing, Meetings, Excel, PowerPoint, Microsoft Word, personnel, posters, presentations, progress, protocols, report writing, research, Safety, scheduling, Scientific, Simulation, statistical analysis, strategic planning, supervisor, training manuals
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Companies Worked For:
Utah Biomedical Test Laboratory
Hazleton Wisconsin, Inc
American Biogenics Corporation/Whitaker ToxiGenics, Inc
University of Illinois
University of North Carolina School of Pharmacy
Southern Illinois University at Carbondale
Job Titles Held:
Senior Scientific Investigator/ Senior Manager/Toxicologist, General Toxicology
Toxicologist/Study Director, Toxicology Department
Study Coordinator/Research Associate
Manager, Acute Toxicology/Toxicology Technician
Bachelor of Science : Biology Integration of New Drug Development Tools into the FDA Regulatory Framework Regulatory Affairs Certificate: Pharmaceuticals Courses - RAPS Online University Effective Responses to FDA Enforcement: Actions in a Risk-Based Environment IND Soup to Nuts - IND Format and Content, the IND Process, Conducting Clinical Trials, and Maintaining the IND Drug Development and FDA Regulations: A Regulatory Overview Preparing for and Facilitating Key FDA Meetings Evaluation of Cardiac Drug Toxicity in Pharmaceutical Discovery and Development Drug Discovery and Development Simulation: Candidate Selection to Launch Impurities: Assessing Safety Risk and Managing Regulatory Impact Due Diligence Training Course Challenges in Development of Anticancer Drugs Pharmacokinetic Applications in Drug Development Master of Science : Biological Sciences Scientific Thinking and Writing
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