PK Scientist II

This is a fully remote position, open to applicants in Canada.

📋 Description

• Perform PK/PD data analysis utilizing non-compartmental analysis techniques.

• Assist in PK/PD modeling and simulations with tools such as Phoenix WinNonlin, NLME, Monolix, R, and similar software.

• Implement strategic direction and vision for PK/PD data analysis to enhance clinical trial designs, compound development plans, and regulatory submissions.

• Create predictive simulations and contribute insights for trial protocol development.

• Offer feedback on clinical trial Statistical Analysis Plans and prepare mock tables, listings, and graph shells, including components related to PK/PD analysis.

• Draft standalone PK/PD Analysis Plans, including mock shells for PK/PD.

• Author and/or review documents and reports related to PK/PD, including study protocols and PK Study Reports.

• Participate in the development of clinical pharmacology sections for protocols, clinical study reports, Investigator's Brochures, briefing documents, and IND/NDA/ANDA submissions.

• Collaborate with regulatory affairs personnel to furnish PK/PD data for regulatory communications and presentations as required.

• Ensure compliance with divisional SOPs, guidelines, therapeutic-area standards, and conventions.

• Stay updated on regulatory and ICH requirements or guidelines pertaining to pharmaceutical drug trials.

• Plan and execute professional development activities.

⛳️ Requirements

• An advanced degree, such as a Ph.D. or M.Sc. in Clinical Pharmacology (including Pharmacokinetics, Pharmacodynamics), Pharmacy, Biopharmaceutics, or a related discipline.

• A minimum of 2 to 4 years of experience as a PK Scientist or in a similar position within the pharmaceutical clinical trial sector.

• Preferred experience in various therapeutic areas and across Phase I to IV clinical trials.

• Proficient in WinNonlin or comparable software.

• Familiarity with other relevant pharmacometric software for non-compartmental analysis, PK/PD analysis, and modeling is advantageous.

• Knowledge of SAS and/or R is preferred, or a willingness to learn and develop SAS expertise.

• Strong understanding of clinical trials and common statistical analysis methods used in clinical studies is preferred.

• Competence in scientific writing and data interpretation is preferred.

• Proven ability to comprehend PK results effectively.

• Capable of communicating efficiently, both verbally and in writing.

• Demonstrated logical thinking, vision, and creativity necessary for functioning independently with minimal supervision.

• Experience in client relationship management is preferred.

• Ability to handle multiple tasks and manage several projects with competing deadlines.

• Excellent interpersonal and teamwork abilities; detail-oriented, customer-focused, and dedicated to quality.

• Well-organized and capable of working autonomously.

• Strong understanding of core PK/PD and statistical principles.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance.

• Life and AD&D insurance coverage.

• Short- and long-term disability benefits.

• Tuition reimbursement program.

• Fitness reimbursement options.

• Employee Assistance Program (EAP).

• Pension plan offerings.

• Generous paid time off and sick leave policies.

• Potential to receive a performance-based bonus.