PK Scientist I

Altasciences • Montreal, QC

1d

About The Position

The PK Scientist I gathers and synthesizes scientific information, performs pharmacokinetic (PK) analysis, and provides high-quality documents to support sponsors’ research programs. The role may serve as the PK representative, nonclinical principal investigator, or contributing scientist on assigned project teams and includes analysis, interpretation, document preparation and review, quality control, and coordination with internal teams.

The position performs non-compartmental PK analyses using Phoenix WinNonlin, conducts toxicokinetic (TK) analyses, and prepares nonclinical reports in accordance with project and client specifications and Good Laboratory Practice (GLP). It prepares or reviews study documents, including protocols, data transfer agreements, protocol deviation impact assessments, sample inventory summaries, PK population determinations, statistical analysis plan sections, clinical study report sections, preliminary results summaries, and standalone reports. Work is conducted in accordance with applicable procedures and regulatory guidance, including SOPs, GCP, ICH guidance, and relevant regulatory authorities’ requirements.

The role also interprets PK results, conducts literature searches as needed, reviews colleagues’ analyses and documents for quality, participates in project meetings and quality improvement initiatives as required, contributes to study risk assessment and management plans, and coordinates timely delivery of high-quality documents. English fluency is essential for this position because of documentation and communication requirements with colleagues and customers.

Requirements

• Bachelor’s degree in Pharmacy, Pharmacology, or a relevant field; experience may be substituted for education.
• Minimum of 2 years of experience as a PK professional.
• 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 multidisciplinary team of professionals.
• Client-focused approach to work.
• Flexible attitude toward work assignments and new learning.
• Ability to prioritize workload.
• Understanding of clinical research, pharmacology and PK, the drug development process, and applicable regulatory guidelines.
• Good computer skills, including Microsoft Word, Excel, and PowerPoint, and ability to understand and adapt to various IT systems.
• Fluency in English.

Nice To Haves

• Experience in a nonclinical TK setting is an asset.

Responsibilities

• Serve as the PK representative, nonclinical principal investigator, or contributing scientist on assigned project teams.
• Review 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.
• 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 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 assist in answering deficiency letters from regulatory agencies, as required.
• Perform literature searches and 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.
• Participate in internal and external project team meetings, as required.
• Coordinate with the internal team to deliver high-quality documents according to agreed timelines.
• Contribute to risk assessment and management plans (RAMPs) for assigned studies.
• Conduct work in compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and regulatory guidelines.
• Maintain familiarity with client expectations and produce analyses and documents consistent with them.
• Maintain awareness of regulatory guidelines from related authorities, including TPD, FDA, and EMA, as well as ICH and GCP procedures.
• Participate in departmental or interdepartmental quality improvement initiatives, as applicable.
• Maintain and participate in the objectives of the department.

Benefits

• Health, dental, and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level