PK Scientist I

Your Role

The PK Scientist is responsible for gathering and synthesizing scientific information, performing pharmacokinetic (PK) and pharmacodynamics (PD) analyses, 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 (as needed) on assigned project teams.
• Review of protocols for studies of moderate to high complexity.
• Contribute to risk assessment and management plans (RAMPs) for assigned studies.
• Prepare and/or review data transfer agreements (DTAs).
• Prepare and/or review protocol deviation impact assessments, sample inventory summaries (SIS), and PK/PD population determinations.
• Prepare and/or review PK/PD sections of statistical analysis plans (SAPs) for studies of moderate to high complexity.
• Perform PK and PD analyses for studies of moderate to high complexity using Phoenix WinNonlin software.
• Analyze and interpret PK and PD results.
• Prepare and/or review of PK/PD sections of clinical study reports (CSRs), preliminary results summaries, and standalone reports for studies of moderate to high complexity in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.
• As needed, perform toxicokinetic (TK) analysis and prepare nonclinical reports in accordance with project/client specifications and Good Laboratory Practice (GLP).
• 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.
• Conduct all work in compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), GLP, 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, GCP, and GLP procedures.
• May participate in departmental or interdepartmental quality improvement initiatives.
• Maintain and participate in the objectives of the department.
• Other duties as assigned.

What you need to succeed:

• Bachelor's Degree in Pharmacy, Pharmacology
• 4 year's experience as a PK Scientist;

• 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, PK, TK, drug development process, and applicable regulatory guidelines.

• Good computer skills (Microsoft Word, Excel, and Power Point and Phoenix WinNonlin) and ability to understand and adapt to various information technology (IT) systems.

What we offer:

• Permanent, full-time position.
• Remote position.

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences’ Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Reviews