Pharmacokinetics Scientist – Non-Compartmental Analysis

6 days ago

Montreal, Quebec, Canada PhInc. Modeling Full time $90,000 - $120,000 per year

We are looking for a Pharmacokinetics (PK) Scientist with hands-on experience in non-compartmental analysis (NCA) to join our team. The successful candidate will support both early- and late-phase clinical trials by performing PK analyses, interpreting results, and contributing to regulatory documents. This role offers a hybrid remote arrangement for qualified applicants. The level of responsibility and autonomy will be tailored to the candidate's experience.

About PhinC Modeling

PhinC Modeling is a fast-growing contract research organization dedicated to advancing drug development. We support programs across all phases and therapeutic areas with a focus on scientific rigor, regulatory compliance, and teamwork.

Key Responsibilities

  • Perform non-compartmental PK analyses using Phoenix WinNonlin (required), and interpret PK data.
  • Contribute to protocol design, especially sections concerning PK objectives, sampling strategy and methods
  • Author and review PK analysis plans and reports for internal and regulatory use.
  • Conduct QC of PK outputs and maintain high documentation standards.
  • Apply knowledge of CDISC standards (SDTM and ADaM) for structuring and reviewing PK datasets and their documentation.
  • Prepare and review data specification documents (DTAs), manage dataset transfers, and ensure datasets are complete, consistent, and ready for import into analysis platforms.
  • Collaborate with clinical, data management, and bioanalytical teams on study planning and PK data management.
  • Manage study timelines and ensure workload follow-up and timely delivery.
  • Communicate findings clearly with internal and external stakeholders.

Additional Responsibilities (Based on Experience)

  • Provide strategic input on study design and regulatory interactions.
  • Lead complex PK projects across development stages.
  • Mentor junior scientists and contribute to internal process improvement.

Qualifications

  • Degree in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, or related field:
  • Bachelor's with 5+ years' experience
  • Master's with 3+ years' experience
  • PhD with 1–3+ years' experience
  • Solid understanding of PK principles and hands-on experience in NCA.
  • Proficiency in Phoenix WinNonlin is required; knowledge of R or SAS is a plus.
  • Familiarity with regulatory guidelines (FDA, EMA) for PK analysis is an asset.
  • Strong written and oral communication in both English and French.
  • Detail-oriented with strong organizational and problem-solving skills.

What We Offer

  • Competitive salary based on experience
  • Comprehensive benefits package
  • Flexible and supportive work environment
  • Career development through training and mentorship

Help us move medicines from lab to life

PhinC Modeling proudly embraces diversity and is an Equal Opportunity Employer.

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