The Associate Pharmacokinetics, an experienced scientist in the area of pharmacology, pharmacokinetics, clinical research and/or biopharmaceutics, plays a lead role in the completion of biostudy related tasks within the BioClinical Development Division. The Associate Pharmacokinetics is responsible for the development of clinical bioequivalence protocols for biostudies, leads biostudy project teams, prepares the pharmacokinetic/statistical section of submission reports and the prepares comprehensive summaries of pharmacology/toxicology information for pharmaceutical products.
Key Job Responsibilities
* Develop protocols (study designs) for bioequivalence studies for both solid and specialized dosage forms, and review protocols prepared by CROs.
* Perform data analysis on clinical and bioanalytical data, and predictive modelling/ simulations of data, as required.
* Write and review relevant sections of pharmacokinetic/statistical reports.
* Prepare the pharmacology/toxicology sections of necessary submission documents.
* Respond to deficiency letters and/or requests for additional information posed by regulatory agencies, pertaining to biostudy designs or results.
* Assess protocol deviations for impact on pharmacokinetic analysis of the data and study integrity.
* Apply expertise and understanding of bioequivalence, pharmacokinetics and regulatory guidelines.
* Apply creativity, depth and breadth of scientific and technical knowledge.
* Utilize knowledge and understanding of biostatistics to describe results.
* Participate in developing and/or updating procedures and policies in the pharmacokinetics department.
* Provide professional and technical expert advice in the field of pharmacokinetics and pharmacology.
* Function as biostudy project team leader, communicating study progress to team members and management.
* Strive to expand the scientific basis of departmental operations and decision making process.
* Train and provide guidance to more junior members of the Pharmacokinetics Department.
* In-depth knowledge and understanding of regulatory requirements for bioequivalence studies.
* Expert knowledge and understanding of pharmacology, pharmacokinetics and physiology.
* Good understanding and command of basic statistical principles and procedures.
* Basic understanding of pharmaceutics.
* Excellent computer skills and knowledge (Microsoft office, basic hardware/software maintenance) and capability to quickly learn and grasp new software packages
* Good team member with desire to help and be helped.
* Excellent organizational skills with high attention to details.
* Ability to work in a strictly regulated environment with very little tolerance for errors.
* Initiative and innovative.
* Proven independent time management and project management capability, deadline oriented.
* Proven independence and decision-making capability.
* Ability and desire to learn.
* Flexibility to respond to a changing and evolving environment.
* Excellent oral and written English communication skills.
* Ability to work under pressure.
* B.Sc in Pharmacy or M.Sc. or Ph.D. in Pharmacokinetics/Pharmacology/ Pharmaceutical Sciences.
* Industry experience is an asset, preferably in the area of bioequivalence, preparing clinical biostudy protocols and compiling submissions for different regulatory agencies. Apotex - 2 years ago