Scientist, Clinical Pharmacokinetics

Key Responsibilities

• Utilizes a variety of analytic software to integrate PK drug concentration-time measures, pharmacodynamic responses, and clinical safety and efficacy information for PK / PD and Modeling and Simulation (M&S) analyses.
• Represents Clinical Pharmacology line function and works on a multi-functional team (clinical, regulatory, biometrics, etc.

to support late-stage discovery programs from preclinical development to IND filing and throughout clinical development.

• Independently analyzes, interprets and reports clinical PK data as a member of several multidisciplinary development program teams.
• Works with clinical teams to design PK components in various study designs, such as first-in-human and drug-drug interaction studies.
• Familiarity with quantitative approaches in drug development with working knowledge of relevant modeling software (e.g. SimCyp, NONMEM)
• Writes and reviews relevant sections of regulatory and scientific documentation including Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans and Clinical Study Reports.
• Maintains a working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
• Develops and maintain a relationship with internal and external clients and scientists.
• Reviewing / Authoring scientific publications, abstracts, posters
• Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced and objective manner.
• Summarizes and presents results to supervisor in a logical manner, verbally and in written reports or presentations. May present data to project team meetings.
• Works closely with SAS programmer and Clinical Operations to ensure deliverables are completed in a time-efficient manner.
• Accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, exposure-response analysis, etc.

Qualifications and Experience

• PhD or equivalent in Pharmacology / Biomedicine / Biochemistry or related scientific discipline with a minimum 3-5 years of relevant experience within a pharmaceutical industry, contract research, or clinical research.
• Solid PK training and experience is a must.
• Experience with clinical development of therapeutic molecules is highly desirable.
• Proficiency using Phoenix Winnonlin for non-compartmental analysis is a must.
• Hands on clinical pharmacology related work experience in regulatory and scientific documentation writing including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports, as well as regulatory documents.
• Advanced spreadsheet skills are desirable.
• Familiarity with PK, ADA and NAb bioanalytical methods development and validation is an asset.
• Exceptional analytical and problem-solving capabilities.
• Effective interpersonal, written and verbal communication skills.
• Strong clinical / scientific writing skills.
• Ability to manage multiple projects, prioritize work, and meet deadlines.
• Capable of anticipating and recognizing potential problems within project plans and effectively communicate alternatives.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
• Hands-on experience with at least 2 modeling and simulation software (e.g., Phoenix WinNonlin, NONMEM, Berkeley Madonna, R, S-Plus, SimCYP, Monolix, and GastroPlus) is strongly preferred.

Total Rewards We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth.

We regularly benchmark our compensation against leading biotechnology companies in our geographies. The Canadian base salary range for this full time position is $94, - $, + bonus + equity + benefits.

Our salary ranges are determined by role, level, and location.

The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all Canadian locations.

Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).

Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits. Our team enjoys :

• Industry leading vacation and paid time off
• Excellent health and wellness benefits
• Zymelife health and wellness benefits
• Paid time off to volunteer in your community
• Matching country specific pension savings program
• Employee Share Purchase Program
• Employee Equity Program

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.