Michael K. Pugsley

About Michael K. Pugsley

Serve as functional leader and subject matter expert in supporting discovery and development projects• Expert in Safety Pharmacology, Toxicology, Cardiac Electrophysiology, In vivo models, Mechanistic & Investigative Toxicology• Contribute to project strategy by providing recommendations to program teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy• Design, execute, manage, analyze, review, summarize, interpret and report results of Toxicology and Safety Pharmacology data to internal project teams and senior management• Provide strategic preclinical expertise to cross-functional teams as the in-house toxicology/safety expert• People management and scientific leadership in Industry & Academia• Pre-clinical R&D safety lead on numerous project teams• Coordinate, oversee and manage Safety Pharmacology core-battery & IND and NDA-enabling GLP Toxicology studies• Cardiovascular and Metabolic, CNS, Diabetes, Antibiotics, Anti-inflammatory, Antihypertensive, Oncology, Atherosclerosis, MI & CHF therapeutic areas of drug development• Design integrated non-clinical safety strategies for small (NCE) and large molecules (including monoclonal antibodies, proteins, peptides)• Extensive network of contacts across the Pharmaceutical and Biotechnology sectors including consultants, scientific experts and thought leaders in both Industry and Academia• Marked expertise in reviewing and providing critical technical evaluation of in-licensing drugs• Support regulatory submissions and interactions with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to toxicology and nonclinical drug development• Manage collaborations with CRO for outsourcing activities and ensure high quality study execution to meet program timelines• Over 125 peer-reviewed publications, book chapters and patents

Experience

1. Senior Director, Toxicology & Safety Pharmacology

   Cytokinetics

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

Education

• The University of British Columbia

  Master of Science (M.Sc.), Autacoid Pharmacology; Cardiac Pharmacology; Shock

  1989 — 1992

• UC Irvine

  Medical Research Council of Canada Post-Doctoral Fellowship, Molecular Biology & Cardiac Ion Channel Electrophysiology

  1995 — 1998

• The University of British Columbia

  Adjunct Professor, Pharmacology & Therapeutics

  2003 — 2009

• The Australian National University

  Visiting Research Scientist, John Curtin School of Medical Research, Ion Channel Biophysics/Electrophysiology

  1993

• The University of British Columbia

  Doctor of Philosophy (Ph.D.), Cardiac Pharmacology/Electrophysiology

  1992 — 1995

• The University of British Columbia

  Bachelor of Science (B.Sc.), Human Pharmacology & Therapeutics

  1985 — 1989

Skills

• Oncology
• Diabetes
• Life Sciences
• Molecular Biology
• Protein Chemistry
• Biologics
• Antibodies
• Biomarkers
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Animal Models
• Inflammation
• R&D
• CRO Management
• Pharmacology
• Good Laboratory Practice (Glp)
• Biotechnology
• Regulatory Submissions
• In Vivo
• Pharmacokinetics
• Ind
• Toxicology
• Glp
• CRO
• Translational Medicine
• In Vitro
• Drug Development
• Biopharmaceuticals
• Clinical Development
• Neuroscience
• Drug Discovery
• Safety Pharmacology
• Monoclonal Antibodies
• Immunology
• Assay Development