Gilles Dube

About Gilles Dube

Senior professional with over 25 years of expertise in drug discovery, development, and operations within large pharmaceutical and small biotech sectors in the USA and Canada. Proven track record in directing programs, research teams, and external collaborations that accelerate the identification and characterization of novel drug candidates, advancing them through non-clinical, IND, and early clinical development phases. Strong understanding of pharmacology, ADME/PK, non-clinical safety and toxicology, CMC, and early clinical development for both small and large molecule therapeutics, including antibodies, engineered live biotherapeutic products and gene therapy. Skilled in developing and adjusting project plans, budgets, and timelines to respond swiftly to evolving corporate priorities while maintaining a comprehensive understanding of business processes related to new technologies, competitive intelligence, and regulatory documentation.• Bilingual in English and French.Fields of Expertise: Biotech Operations Management; Drug Discovery, Non-Clinical Development, Multiple Therapeutic Areas, Project Management

Experience

1. Senior Director of Preclinical Development

   Neurocrine Biosciences

   Nov 2020 — Present · San Diego County, CA, US

   Reporting to the VP Preclinical, track and manage preclinical timelines and activities for all late-stage research and development candidate assets at Neurocrine. Liaise with research, CMC and PCLN team members to ensure that all functional lines are aligned and able to support lead characterization and IND-enabling activities. Provides regular updates to senior management. Manage authoring, reviewing and QC of research and preclinical sections of regulatory documents (e.g, IND, CTAs) to support new regulatory submissions. Serve as the preclinical point-person for all inquiries. Liaise with all relevant functional lines, e.g. regulatory affairs, medical writing, program management, regulatory operation to ensure smooth execution of regulatory submissions. Track, gather, organize all relevant documentation to support regulatory submissions (e.g, internal and CRO-generated technical reports, literature) Core team preclinical representative for selected programs including within the epilepsy franchise. Preclinical point person for several external collaborations – working closely with alliance management and business development.

Education

• Université Laval

  B.Sc., Biochemistry

  1984 — 1987

• University of Ottawa

  M.Sc., Physiology/ cardiovascular

  1989 — 1992

• University of Ottawa

  Ph.D., Physiology/Neuroscience

  1992 — 1997

• Massachusetts Institute of Technology

  PostDoc, Neuroscience

  1998 — 2001

Skills

• Inflammation
• Cell Biology
• Biotechnology
• Electrophysiology
• U.s. Food and Drug Administration (Fda)
• Regulatory Affairs
• Lifesciences
• Life Sciences
• Ion Channels
• Lead Optimization
• Pharmaceutical Research
• Clinical Trials
• Science
• Biochemistry
• Pharmaceutics
• Drug Discovery
• Pain Management
• Standard Operating Procedure (Sop)
• Ind
• Biomarker Discovery
• Acute Kidney Injury
• Lead Change
• Pain
• CRO Management
• Research
• R&D
• Physiology
• Assay Development
• Cell
• Pharmacokinetics
• Drug Development
• Chronic Kidney Disease
• Target Identification
• Pharmacology
• Cell Culture
• Chronic Pain
• In Vitro
• In Vivo
• Pharmaceutical Industry
• Fda