Principal PK Scientist

Job not on LinkedIn

🔥 7 minutes ago

🇨🇦 Canada – Remote

💵 $130k - $160k / year

⏰ Full Time

🔴 Lead

👻 Ghost score 0%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Provide strategic clinical pharmacology, pharmacokinetic, pharmacodynamic, and pharmacometric expertise for clinical trial design, compound development plans, regulatory strategies, and drug development decisions • Serve independently as lead PK/PD scientist on large, complex, or high-profile development programs • Consult with Sponsors on clinical pharmacology strategy, 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 guidance to PK Scientists and Senior PK Scientists • Support onboarding and training initiatives • Develop and maintain departmental SOPs, guidance documents, standards, templates, and working practices • Participate in scientific publications, conference presentations, and external professional activities • Lead and oversee 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 using WinNonlin®, NLME, Monolix, Simulx, R, and other relevant software • Generate predictive simulations for dose selection, study design optimization, and regulatory interactions • Interpret PK/PD data and communicate 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 documents • Contribute to INDs, NDAs, BLAs, and other global regulatory submissions • Participate in regulatory meeting preparation and scientific interactions with health authorities • Review clinical pharmacology and pharmacometric deliverables from internal teams or external vendors • Support proposal development, bid defenses, capability presentations, feasibility assessments, and budget development • Contribute scientific expertise to RFPs and client opportunities • Identify opportunities to expand Clinical Pharmacology and Drug Development capabilities and service offerings • Lead or contribute to initiatives focused on innovation, automation, operational efficiency, and scientific advancement • Plan and carry out professional development activities

🎯 Requirements

• 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 • 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

• 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