Canada
Accomplished and passionate executive with a proven track record with 25+ years providing operational management, scientific leadership, consulting, and technical sales to the pharmaceutical and biotech industries. Technical knowledge across the ADME discipline, with particular depth in radiolabel studies from in vitro, non-clinical to clinical hAME studies and dosimetry. Knowledge of regulatory requirements for IND and NDA-enabling DMPK programs including bioanalysis, metabolites in safety testing, drug-interaction, and radioprofiling/excretion/mass balance studies. Creative leader effective in achieving critical business objectives and meeting performance targets by leveraging strong influencing and communication skills to build win-win relationships with diverse business partners and stakeholders. Early career experience in academia in both teaching and grant funded research programs in the area of radiation biology.
Provide consultancy services to pharmaceutical and biotech companies in the areas of non-clinical and clinical DMPK/ADME studies, including; project lead to design and manage IND and NDA-enabling ADME programs for drug metabolism, PK, DDI, and radiolabel studies, vendor management, report review and preparation, gap analysis, as well as human radiolabel dosimetry estimations.
Provided consulting services to pharmaceutical and biotech companies in the areas of non-clinical and clinical PK/ADME studies, including; study design, project management, vendor management, report review, gap analysis, and human radiolabel dosimetry estimations.
Responsible for site operations, technical consulting and business development for DMPK/ADME and bioanalytical services, as well as client management at the NJ Site of WuXi AppTec's Lab Testing Division.
Led business development efforts in North America; evaluated pharmaceutical/biotech/drug delivery company products for their need for nuclear gamma scintigraphy imaging and regional gut absorption services.
Conducted human radiolabel (hAME) studies, nuclear medicine imaging studies and dosimetry, Radiation Safety Officer