Principal PK Scientist

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

📋 Description

• Deliver strategic expertise in clinical pharmacology, pharmacokinetics, pharmacodynamics, and pharmacometrics for clinical trial design, compound development plans, regulatory strategies, and drug development decisions.

• Act independently as the lead PK/PD scientist on large, complex, or high-profile development programs.

• Collaborate with Sponsors on clinical pharmacology strategies, PK/PD study design, dose selection, exposure-response analyses, and model-informed drug development.

• Identify development risks and propose mitigation strategies related to study design, PK sampling, endpoint selection, population selection, and clinical pharmacology assessments.

• Mentor, coach, and provide scientific direction to PK Scientists and Senior PK Scientists.

• Assist with onboarding and training initiatives.

• Develop and uphold departmental SOPs, guidance documents, standards, templates, and working practices.

• Engage in scientific publications, conference presentations, and external professional activities.

• Lead and supervise compartmental and non-compartmental analyses, population PK/PD modeling, exposure-response analyses, disease progression modeling, and model-informed drug development activities.

• Create and manage modeling and simulation strategies using WinNonlin®, NLME, Monolix, Simulx, R, and other pertinent software.

• Produce predictive simulations for dose selection, study design optimization, and regulatory interactions.

• Analyze PK/PD data and convey findings to multidisciplinary teams and Sponsors.

• Author or scientifically review PK Analysis Plans, PK/PD Analysis Plans, Modeling and Simulation Analysis Plans, Clinical Study Reports, Clinical Pharmacology Reports, Investigator’s Brochures, briefing documents, and regulatory submission documentation.

• Contribute to INDs, NDAs, BLAs, and other global regulatory submissions.

• Participate in regulatory meeting preparations and scientific interactions with health authorities.

• Review clinical pharmacology and pharmacometric deliverables from internal teams or external vendors.

• Assist with proposal development, bid defenses, capability presentations, feasibility assessments, and budget preparation.

• Provide scientific expertise for RFPs and client opportunities.

• Discover opportunities to enhance Clinical Pharmacology and Drug Development capabilities and service offerings.

• Lead or contribute to initiatives aimed at innovation, automation, operational efficiency, and scientific advancement.

• Plan and execute professional development activities.

⛳️ Requirements

• Doctor of Philosophy degree in Clinical, Medical, or Life Sciences, or a Master’s degree with significant experience in the subject matter.

• At least 8 years of experience in PK/PD within the pharmaceutical clinical trial setting.

• Proven experience leading a team with exceptional people management skills across various functional areas within the company.

• Strong verbal and written communication abilities.

• Proficient in using WinNonlin®, NLME®, Monolix™, R, or other relevant pharmacometrics software for PK/PD analysis and modeling.

• Excellent understanding of clinical trials and standard clinical trial statistical analysis methods.

• Demonstrated capability to comprehend medical information and pharmacology results; able to communicate effectively, both orally and in writing.

• Experience in multiple therapeutic areas and Phase I through IV clinical trials is advantageous.

• Background in medical writing for clinical research, including Clinical Study Reports, other regulatory submission documents, and scientific publications.

• Proven experience, knowledge, and understanding of Good Clinical Practice/ICH guidelines, including E3 Structure and Content of Clinical Study Reports.

• Capable of managing multiple projects and clients; experienced in client relationship management.

• Strong organizational skills, with the ability to adapt to changing priorities and manage multiple assignments with conflicting deadlines.

• Ability to maintain a high degree of confidentiality regarding clinical data and client proprietary information.

• Detail-oriented, with a customer- and quality-focused mindset.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• Pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.