Serves as the primary point of contact for Study Sponsors to enable the design, development and completion of study protocols and insures successful completion of all study activities while meeting all required time lines. Duties include study scheduling and monitoring of inlife and all other study-related activities, review of IACUC protocols, resource coordination, facilitation of dose formulation, data analysis including final determinations of test article affect, and results reporting. Liaison between staff and client to ensure both internal and client expectations for quality and timeliness are met. Assist in the development and continuous improvement of best practices for all study activities. Interface with client product teams regarding product testing strategies. May assist in development of specialized techniques to meet study objectives.

Responsible for leading the In-Life Group to insure scientifically sound execution of in vivo pharmacokinetic, toxicology and pharmacology studies. Key activities include providing scientific and technical input to Study Directors during study protocol generation, assisting Study Coordinators in timely communication with Principle Investigators or Study Directors regarding study activities. Additional business-critical activities include facilitating study scheduling and resourcing with Study Directors/Study Coordinators, technical skills training of staff, monitoring study activities and work processes to insure Best Practice principles are followed. Responsible for insuring that the In-Life staff attends all required safety and facility training classes as well as compliance with regulatory procedures including documentation. Generation of new Animal User Protocols (AUP) or protocol amendments to enable novel technical activities to support Sponsor studies and general monitoring of in vivo studies are critical activities. Strategic planning activities include forecasting hiring of additional employees, identification and development of novel in vivo models, coordination with Seventh Wave Laboratories scientists to design model validation studies and participate in business development plans.

Managed drug development pharmacology teams that delivered critical data required for endorsement and initiation of Phase 2 clinical trials to support atherosclerosis, liver fibrosis and pulmonary arterial hypertension therapeutic areasLed multi-disciplined, cross-site in vivo pharmacology teams and generated efficacy, biomarker and pk/pd data required for translation to human clinical efficacy.Managed sample collection and analytical logistics utilizing partner lines and external CRO’s.

Leader of drug development pharmacology team that delivered robust drug efficacy, biomarker and safety data demonstrating utility of a novel anti-thrombotic agent, critical to endorsement of Phase 1 clinical trials. Established in vivo pharmacology thrombosis and in vitro platelet aggregation lab and generated key translational pharmacology data. Authored key sections of documents for internal study reports and Investigators Brochure required for FDA submissions to support the preclinical program. Leader of cross-functional/cross-therapeutic area team to establish and validate canine model of renal dysfunction and generated key efficacy data that drove decision to progress to human Phase 1 clinical trials. . Established, validated and tested compounds in in vitro selectivity and cytotoxicity screening assays, acute in vivo models and chronic in vivo surgical models.

Led drug development pharmacology team that implemented multiple clinically relevant preclinical animal models of hypercholesterolemia and atherosclerosis and identified a drug candidate that progressed to human Phase II clinical testing. Developed a high-throughput fecal bile acid assay and compound screening model. Developed and implemented animal models and assays to assess the effect of LXR nuclear receptor agonist’s and antagonist’s on tissue gene expression and lipid profiles. Led a team that implemented a volume-contracted canine model to investigate the effect of compounds on renal blood flow.

Established multiple in vitro models of leukocyte adhesion, chemotaxis and diapedesis studies. Established in vitro models of drug absorption models utiliziing commercially available cell lines and primary cell lines generated from bovine brain endothelium, rodent and human upper respiratory tissue. Established in vitro cell culture models utilizing primary cultures of rat brain, spinal cord and peripheral neurons to screen for growth factor and neuroprotective activity in a stroke model .

Performed cell fusions and clone selection, generated monoclonal antibodies to human colon cancer antigens. Conjugated Mab to imaging agent, approved by FDA for colon cancer detection.

CNS/PNS primary cell culture model development to investigate neuronal plasticity, regeneration and cell signaling.