PK Scientist I

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

• Collect and consolidate scientific data.

• Conduct PK analysis and deliver high-quality documentation to support sponsors' research initiatives.

• Act as the PK liaison, nonclinical principal investigator, or contributing scientist within assigned project teams.

• Evaluate protocols for studies of moderate complexity.

• Draft or assess data transfer agreements, protocol deviation impact assessments, sample inventory summaries, and PK population determinations.

• Create or review PK segments of statistical analysis plans.

• Execute non-compartmental PK analysis utilizing Phoenix WinNonlin.

• Conduct toxicokinetic analysis and prepare nonclinical reports in alignment with project/client specifications and GLP standards.

• Analyze and interpret PK results.

• Prepare or review PK sections of clinical study reports, preliminary results summaries, and independent reports in accordance with ICH E3 guidelines.

• Review and assist in addressing regulatory agency deficiency letters.

• Carry out literature searches and analyses.

• Perform quality-control assessments of analyses and documentation.

• Engage in internal and external project-team meetings.

• Collaborate with internal teams to ensure timely delivery of documents.

• Contribute to risk assessment and management plans.

• Conduct work in accordance with SOPs, GCP, and regulatory standards.

• Maintain an understanding of client expectations and produce consistent analyses and documentation.

• Participate in quality improvement initiatives and departmental goals.

⛳️ Requirements

• Bachelor’s Degree in Pharmacy, Pharmacology, or a related field (experience may be considered in lieu of education).

• At least 2 years of experience in PK.

• Experience in a nonclinical TK environment is advantageous.

• Proficiency with Phoenix WinNonlin.

• Strong verbal and written communication skills.

• Professional demeanor and excellent interpersonal abilities.

• Capability to rapidly acquire and apply new knowledge.

• Ability to collaborate effectively with a multidisciplinary team of professionals.

• Client-centered approach to work.

• Adaptable attitude towards work assignments and continuous learning.

• Strong prioritization skills for workload management.

• Knowledge of clinical research, pharmacology and PK, the drug development process, and relevant regulatory guidelines.

• Proficient computer skills (Microsoft Word, Excel, and PowerPoint) and the ability to navigate various information technology (IT) systems.

• Fluency in English is a mandatory requirement for this position.

🏝️ Benefits

• Health, dental, and vision insurance plans.

• RRSP with employer matching.

• Paid vacation and statutory holidays.

• Paid sick leave and bereavement leave.

• Employee assistance and telehealth programs.

• Opportunities for training and development.

• Employee orientation bonus program.

• Annual performance evaluations.