[Hiring] Principal PK Scientist @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Principal PK Scientist for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Responsibilities

• Scientific Leadership and Strategic Consultation:
  • Provide strategic clinical pharmacology, pharmacokinetic, pharmacodynamic, and pharmacometric expertise to support clinical trial design, compound development plans, regulatory strategies, and drug development decision-making.
  • Independently serve as lead PK/PD scientist on large, complex, or high-profile development programs.
  • Provide scientific consultation to Sponsors regarding clinical pharmacology strategy, PK/PD study design, dose selection, exposure-response analyses, and model-informed drug development approaches.
  • Identify potential development risks and propose mitigation strategies related to study design, PK sampling schedules, endpoint selection, population selection, and clinical pharmacology assessments.
  • Stay current with emerging regulatory expectations, scientific developments, and industry best practices related to clinical pharmacology and pharmacometrics.
  • Provide technical mentorship, coaching, and scientific guidance to PK Scientists and Senior PK Scientists.
  • Support onboarding and training initiatives within the Clinical Pharmacology and Drug Development group.
  • Contribute to the development and maintenance of departmental SOPs, guidance documents, standards, templates, and working practices.
  • Maintain expertise in clinical pharmacology, pharmacometrics, drug development, regulatory science, and emerging modeling methodologies.
  • Participate in scientific publications, conference presentations, and external professional activities as appropriate.
  • Plan and carry out professional development activities.
• Pharmacometric Modeling and Data Analysis:
  • Lead, conduct, and oversee advanced compartmental and non-compartmental analyses, population PK/PD modeling, exposure-response analyses, disease progression modeling, and model-informed drug development activities.
  • Develop and oversee modeling and simulation strategies utilizing WinNonlin®, NLME, Monolix, Simulx, R, and other relevant software platforms.
  • Generate predictive simulations to support dose selection, study design optimization, and regulatory interactions.
  • Provide strategic interpretation of PK/PD data and communicate findings to multidisciplinary teams and Sponsors.
• Regulatory and Scientific Documentation:
  • Author and/or provide scientific review of 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 documents.
  • Contribute to INDs, NDAs, BLAs, and other global regulatory submissions.
  • Participate in preparation for regulatory meetings and scientific interactions with health authorities.
  • Provide expert review of clinical pharmacology and pharmacometric deliverables generated by internal teams or external vendors.
• Business Development and Innovation:
  • Support proposal development, bid defenses, capability presentations, feasibility assessments, and budget development activities.
  • Contribute scientific expertise to Requests for Proposal (RFPs) and client opportunities.
  • Identify opportunities to expand Everest's Clinical Pharmacology and Drug Development capabilities and service offerings.
  • Lead or contribute to departmental initiatives focused on innovation, automation, operational efficiency, and scientific advancement.

Qualifications

• Doctor of Philosophy degree in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
• Minimum 8 years’ experience in PK/PD in the pharmaceutical clinical trial environment.
• Experience leading a team with exceptional people management skills in dealing with the various functional areas within the company.
• Strong verbal and written communication skills.
• Proficient in using WinNonlin®, NLME®, Monolix™, R, or other relevant pharmacometrics software for PK/PD analysis and modeling.
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
• Demonstrated ability to understand medical information and pharmacology results; able to communicate effectively, orally, and in writing.
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods; experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
• Experience with medical writing for clinical research, including CSRs, other regulatory submission documents, and scientific publications.
• Demonstrated experience, knowledge, and understanding of Good Clinical Practice/ICH guidelines, including E3 Structure and Content of CSRs.
• Ability to handle multiple projects and clients; experience with client relationship management.
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
• Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
• Detail-oriented, customer- and quality-focused.

Benefits

• Robust benefits package to support your health, well-being, and growth, including 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.