PK Scientist I

Job description

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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