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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