PK Scientist II

🔥 9 minutes ago

🇨🇦 Canada – Remote

💵 $105k - $120k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 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

• Conduct PK/PD data analysis using non-compartmental analysis • Support PK/PD modeling and simulations using Phoenix WinNonlin, NLME, Monolix, R, and related software • Apply strategic direction and vision on PK/PD data analysis to support clinical trial designs, compound development plans, and regulatory submissions • Generate predictive simulations and provide input into trial protocol development • Provide input into clinical trial Statistical Analysis Plans and mock tables, listings, and graphs shells, including PK/PD analysis components • Author standalone PK/PD Analysis Plans, including PK/PD mock shells • Author and/or review PK/PD-related documents and reports, including protocols and PK Study Reports • Contribute to clinical pharmacology sections of protocols, clinical study reports, Investigator's Brochures, briefing documents, and IND/NDA/ANDA submissions • Work with regulatory affairs personnel to provide PK/PD data for regulatory communications and presentations as needed • Maintain and adhere to divisional SOPs, guidelines, therapeutic-area standards, and conventions • Keep current with pharmaceutical drug trial regulator and ICH requirements or guidelines • Plan and carry out professional development

🎯 Requirements

• Advanced degree, Ph.D., or M.Sc. in Clinical Pharmacology (including Pharmacokinetics, Pharmacodynamics), Pharmacy, Biopharmaceutics, or related field • At least 2 to 4 years’ experience as a PK Scientist or related role in the pharmaceutical clinical trial environment • Experience in multiple therapeutic areas and Phase I through IV clinical trials is preferred • Proficient in using WinNonlin, or equivalent • Other relevant pharmacometric software for non-compartmental analysis, PK/PD analysis, and modeling is preferred • Familiarity with SAS and/or R is preferred (or willingness to learn and master SAS skills) • Excellent understanding of clinical trials and common clinical trial statistical analysis methods is preferred • Skilled in scientific writing and data interpretation is preferred • Demonstrated ability to understand PK results • Able to communicate effectively, orally and in writing • Demonstrated ability for logical thinking, vision, and creativity necessary to function effectively with a large degree of independence and little supervision • Experience with client relationship management is preferred • Ability to multi-task and manage multiple projects with competing and aggressive timelines • Excellent interpersonal and teamwork skills; detail-oriented, customer-, and quality-focused • Well organized and able to work independently • Strong understanding of fundamental PK/PD and statistical principles

🏖️ Benefits

• Medical, dental, and vision coverage • Life and 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