Emilie Simard Email & Phone Number

Montréal, Québec, Canada

Montreal, Quebec, Canada

Région De Montréal, Canada

Responsible for reviewing and interpreting scientific information for the purpose of providing high-quality scientific documents to support sponsors' research programs for investigational drugs, biologicals, or medical devices. This includes pharmacokinetic and pharmacodynamic data analysis (NCA) and scientific interpretation of study results. Also provide scientific support to the other company divisions and acts as a scientific consultant with the clients. Work planning, staff management as well as creation of key performance indicators. Provide internal training. Manage a small scientist team Manage phase I studies (mainly), toxicokinetic and bioequivalence from a scientific perspective Standalone PK/PD/TK studies Act as a support to the other scientists with Phoenix WinNonlin Developed Phoenix WinNonlin workflow template for automated noncompartmental analyses or any other project specific analyses that allowed other scientist to save time.

Responsible for reviewing and interpreting scientific information for the purpose of providing high-quality scientific clinical study reports to support sponsors' research programs for investigational drugs, biologicals, or medical devices. This includes pharmacokinetic and pharmacodynamic data analysis and scientific interpretation of study results. Also provides scientific support to the other company divisions and acts as a scientific consultant with the clients. Provides internal training.

Perform PK and PK/PD analyses using state-of-the-art methods and according to current regulatory requirements across various phases of drug development. Perform analyses using two or more of the following methods: non-compartmental, compartmental, statistical modeling, IVIVC, PBPK, dose-response modeling, and population PK-PK/PD modeling. Devise and quality control SAS® (or similar) program codes to facilitate the construction of datasets (e.g. NONMEM, clinical datasets, SAS transport files, define.xml) in support of advanced PK/PD modeling and simulation analyses. Write reports and provide interpretation of results suitable for submission to regulatory agencies. Perform quality control (QC) of PK/PD analyses and reports prepared by other PCS scientists. Provide mentoring in PK-PK/PD analysis and related standard operating procedures. Ensure that project budgets and timelines are well-understood and respected. Collaborate with teams of scientific professionals in pharmaceutical and biotechnology companies involved in the development of small and large molecule drugs. Work collaboratively with other PK/PD and biostatistics experts within Pharsight. Interface with other functions within Pharsight (e.g. project management, QA) to ensure timely delivery of projects to clients’ expectations. Provides internal training to Associate Scientists.

Montréal

Responsible for PK and PK/PD analyses and reporting using state-of-the-art methods and software. Perform noncompartmental and compartmental PK/PD modeling in various phases of drug development. Perform PK/PD modeling, dose-response modeling and statistical analyses according to state-of-the-art methods and regulatory requirements. Collaborate with a team of scientific professionals for some of the world’s major pharmaceutical and biotechnology companies involved in the development of small and large molecules. Apply knowledge and experience in noncompartmental and compartmental analysis to investigate dose‑response and population PK/PD relationships to support drug development

Quality AssuranceCreation and revision of medical devices specificationsInspection of medical devicesRevision of ArtworkManagementGMP, ISO 13485

Performing and interpreting pharmacokinetic analysis, report writing, assessing the impact of all clinical events on the objectives of the study from a pharmacokinetic perspective.

Under the supervision of Dr. Vincent Pichette.* Research on the impact of chronic renal failure on phase II drug-metabolizing enzymes.* CYP450, acetylation, glucuronidation, transport. * Standard PCR, real-time PCR, Western blot, immunoprecipitation, HPLC, cell and bacterial culture, cloning, enzymatic activity. I use to work with rats and mice and I assisted many surgeries (nephrectomies).

D.E.S.S, Drug Development; Option; Clinical Research; Pharmacology

M. Sc., Pharmacologie

Project: Effect of chronic renal failure on drug metabolism. Phase II enzymes, mainly acetylation and glucuronidation. Projet.

B. Sc., Sciences Biomédicales

Baccalaureat, Biologic Sciences

First year completed.