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Open nowPosted today

PK Scientist I

Altasciences75 open roles

Where
Laval Quebec
Work mode
Remote
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Your applicationOpen nowPK Scientist IAltasciences · Laval Quebec
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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Altasciences postings stay open a median of 14 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted today

Altasciences median: 14 days open

The posting

About The Role The PK Scientist I is responsible for gathering and synthesizing scientific information, performing PK analysis, and providing high-quality documents to support sponsors' research programs.

What You'll Do Here

  • Serve as the PK representative or nonclinical principal investigator or contributing scientist on assigned project teams.
  • Review of protocols for studies of moderate complexity.
  • Prepare and/or review data transfer agreements (DTAs).
  • Prepare and/or review protocol deviation impact assessments, sample inventory summaries (SIS), and PK population determinations.
  • Prepare and/or review PK sections of statistical analysis plans (SAPs) for studies of simple to moderate complexity.
  • Perform non-compartmental PK analysis for studies of simple to moderate complexity using Phoenix WinNonlin software.
  • Perform toxicokinetic (TK) analysis and prepare nonclinical reports in accordance with project/client specifications and Good Laboratory Practice (GLP).
  • Provide critical interpretation of PK results.
  • Prepare and/or review of PK sections of clinical study reports (CSRs), preliminary results summaries, and standalone reports for studies of simple to moderate complexity in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.
  • Review and provide assistance in answering deficiency letters from regulatory agencies, as required.
  • Perform literature searches/reviews as necessary to obtain background information for analyses and interpretation.
  • Perform quality control (QC) review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.
  • Actively participate in internal and external project team meetings, as required.
  • Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.
  • Contribute to risk assessment and management plans (RAMPs) for assigned studies.
  • Conduct all work in compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and all regulatory guidelines.
  • Maintain familiarity with client expectations and produce analyses and documents consistent with these.
  • Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as ICH and GCP procedures.May participate in departmental or interdepartmental quality improvement initiatives.
  • Maintain and participate in the objectives of the department.

What You'll Need to Succeed

  • Bachelor’s Degree in Pharmacy, Pharmacology, or relevant field (experience may be substituted for education)
  • Minimum of 2 years experience as PK.
  • Experience in a non clinical TK setting an asset.
  • Experience with Phoenix WinNonlin.
  • Excellent verbal and written communication skills.
  • Professional attitude and strong interpersonal skills.
  • Ability to acquire and apply knowledge quickly.
  • Ability to work well with a multi-disciplinary team of professionals.
  • Client-focused approach to work.
  • Flexible attitude with respect to work assignments and new learning.
  • Ability to prioritize workload.
  • Understanding of clinical research, pharmacology and PK, drug development process, and applicable regulatory guidelines.
  • Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.

Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of PK Scientist I including, but not limited to, for the following reasons:

  • The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
  • The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices.
  • The employee frequently communicates with English-only customers outside the province of Quebec.

What We Offer

Altasciences offers a wide range of benefits to help employees live healthy and satisfying lives, both on and off the job.

Altasciences benefits include

  • Health/dental/vision insurance plans
  • RRSP with employer match
  • Paid vacation and statutory vacations
  • Paid sick leave and bereavement leave
  • Employee assistance and telehealth programs

Altasciences' incentive programs include

  • Training and development programs
  • Employee orientation bonus program
  • Annual performance reviews

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