[Hiring] PK Scientist I @Altasciences

Role Description

The PK Scientist I is responsible for gathering and synthesizing scientific information, performing PK analysis, and providing high-quality documents to support sponsors' research programs.

• Serve as the PK representative or nonclinical principal investigator or contributing scientist on assigned project teams.
• Review of protocols for studies of moderate complexity.
• Prepare and/or review data transfer agreements (DTAs).
• Prepare and/or review protocol deviation impact assessments, sample inventory summaries (SIS), and PK population determinations.
• Prepare and/or review PK sections of statistical analysis plans (SAPs) for studies of simple to moderate complexity.
• Perform non-compartmental PK analysis for studies of simple to moderate complexity using Phoenix WinNonlin software.
• Perform toxicokinetic (TK) analysis and prepare nonclinical reports in accordance with project/client specifications and Good Laboratory Practice (GLP).
• Provide critical interpretation of PK results.
• Prepare and/or review of PK sections of clinical study reports (CSRs), preliminary results summaries, and standalone reports for studies of simple to moderate complexity in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.
• Review and provide assistance in answering deficiency letters from regulatory agencies, as required.
• Perform literature searches/reviews as necessary to obtain background information for analyses and interpretation.
• Perform quality control (QC) review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.
• Actively participate in internal and external project team meetings, as required.
• Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.
• Contribute to risk assessment and management plans (RAMPs) for assigned studies.
• Conduct all work in compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and all regulatory guidelines.
• Maintain familiarity with client expectations and produce analyses and documents consistent with these.
• Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc.) as well as ICH and GCP procedures.
• May participate in departmental or interdepartmental quality improvement initiatives.
• Maintain and participate in the objectives of the department.

Qualifications

• Bachelor’s Degree in Pharmacy, Pharmacology, or relevant field (experience may be substituted for education).
• Minimum of 2 years experience as PK.
• Experience in a non clinical TK setting an asset.
• Experience with Phoenix WinNonlin.
• Excellent verbal and written communication skills.
• Professional attitude and strong interpersonal skills.
• Ability to acquire and apply knowledge quickly.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Understanding of clinical research, pharmacology and PK, drug development process, and applicable regulatory guidelines.
• Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.
• Fluency in English is an essential requirement for the position.

Benefits

• Health/dental/vision insurance plans.
• RRSP with employer match.
• Paid vacation and statutory vacations.
• Paid sick leave and bereavement leave.
• Employee assistance and telehealth programs.
• Training and development programs.
• Employee orientation bonus program.
• Annual performance reviews.