PK Scientist I

Altasciences; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health/dental/vision insurance

RRSP with employer match

Paid vacation & holidays

Job summary

Altasciences is seeking a PK Scientist I to gather and synthesize scientific information, perform PK analyses, and produce high-quality documents to support sponsors’ research programs.

You will serve as PK representative on project teams, review protocols, and prepare PK sections of SAPs and CSRs in line with ICH E3 guidance. Strong communication, teamwork, and regulatory awareness are essential for success.

Qualifications

• Bachelor’s degree required; experience may substitute for education.
• Minimum of 2 years experience as PK.
• Experience with nonclinical TK is a plus.
• Proficient in Phoenix WinNonlin.
• Strong verbal and written communication.
• Ability to work with multi-disciplinary teams.
• Knowledge of regulatory guidelines (GCP/ICH/GLP).
• Proficient user of Microsoft Word/Excel/PowerPoint.

Responsibilities

• Serve as PK representative or nonclinical PI on project teams.
• Review moderately complex study protocols.
• Prepare/review data transfer agreements (DTAs).
• Prepare/review PK sections of SAPs for studies of simple to moderate complexity.
• Perform non-compartmental PK analysis using Phoenix WinNonlin.
• Perform TK analysis and prepare nonclinical reports per GLP.
• Provide interpretation of PK results and contribute to CSRs and ICH E3 reports.
• Review deficiency letters from regulatory agencies as needed.
• Maintain familiarity with client expectations and regulatory guidelines.

Skills

Verbal and written communication

Interpersonal skills

Teamwork in multi-disciplinary teams

Client-focused approach

Adaptability/quick learning

Prioritization of workload

Regulatory knowledge (GxP/ICH)

IT skills (MS Office)

Education

Bachelor’s Degree in Pharmacy, Pharmacology, or relevant field

Tools

Phoenix WinNonlin

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