Principal PK Scientist

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

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.

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.

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.

Everest is inviting candidates to apply to this existing vacancy.

Benefits & Compensation:

We offer a 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), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $130,000 - $160,000.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

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