About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

The Scientist, Clinical Research and Development (R&D) is a skilled, research-oriented professional who brings expertise in the area of clinical pharmacology and pharmacokinetics (PK) to support Global R&D activities pertaining to clinical trials. This includes clinical scientific literature evaluation in support of product development, development of Bioequivalence (BE) study designs, performing data analysis and its interpretation, review of clinical study reports and writing comprehensive summaries of pharmacological information for regulatory submission.
Apotex requires clinical studies to be managed in support of development of generic products in a wide range of dosage forms including solid / liquid oral products, topical, respiratory, transdermal and other specialty products spanning large molecule biologics to nanotechnology products. The clinical studies generally involve evaluation of the relative bioavailability compared to that of the brand reference product, with the aim of demonstrating bioequivalence (BE).

** Please note, this is an 18-month contract position with benefits**

Job Responsibilities
Perform in depth scientific data mining, critical evaluation and interpretation of pharmacological, pharmacokinetic (PK), pharmacodynamic (PD) and biopharmaceutical literature information.
Evaluate and interpret PK/PD data generated in clinical trials performed by Apotex and/or Contract Research Organizations (CROs).
Recommend study designs for the development of clinical protocols for BE studies of solid, liquid and specialized dosage forms based on critical evaluation of available scientific information.
Review clinical study protocols and clinical study reports (CSRs) for scientific content, data accuracy and compliance with current regulatory guidelines.
Monitor the progress of clinical studies during the study conduct, by reviewing and assessing communication updates provided by CROs.
Apply expertise and understanding of BE and statistics to review and/or replicate the PK/statistical analysis prepared by CROs.
Prepare or review necessary submission documents related to clinical trials (i.e. CSRs, Biowaivers, Comprehensive Summaries of BE.
Write scientifically in-depth responses to support routine and/or complex regulatory agency queries.
Perform PK modelling and/or simulations, as required.
Participate in scientific discussions on assigned projects to aid in decision making.
Independently acquire and maintain knowledge of local and international regulatory guidelines.
Job Requirements
4 years for B.Sc, 2 years for M.Sc, and 1 year for Ph.D. of industry experience in the area of BE, preparing study protocols and compiling scientific submission documents for different regulatory agencies.
B.Sc, M.Sc. or Ph.D. in pharmacology/pharmacokinetics/pharmaceutical sciences, or Pharmacy degree (B.Pharm).
Technical expertise in the area of PK, pharmacology and physiology.
Strong understanding and command of basic statistical principles and procedures.
Excellent working knowledge of regulatory requirements for BE studies.
Ability to compile information to write in a concise, logical and scientifically sound manner.
Excellent computer skills (Microsoft office, PK/Statistical data packages).
Good team member with desire to help and be helped.
Excellent time management with high attention to details along with project management skills.
Ability to work under pressure in a demanding, strictly regulated environment with very little tolerance for errors.
Flexibility in response to a changing and evolving deadline-oriented environment.
Excellent oral and written communication skills.
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.