Scientist, Clinical Pharmacokinetics Specialist

1 month ago

Vancouver, British Columbia, Canada Zymeworks Full time
Job Title: Scientist, Clinical Pharmacokinetics

At Zymeworks, we are seeking a highly skilled Scientist, Clinical Pharmacokinetics to join our team. As a key member of our Clinical Pharmacology group, you will be responsible for providing scientific expertise and support to our late-stage discovery programs.

Key Responsibilities:
  • Utilize advanced 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.
  • Represent Clinical Pharmacology line function and work collaboratively with cross-functional teams to support late-stage discovery programs from preclinical development to IND filing and throughout clinical development.
  • Analyze, interpret, and report clinical PK data as a member of multidisciplinary development program teams.
  • Work 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 and working knowledge of relevant modeling software (e.g. SimCyp, NONMEM).
  • Write and review relevant sections of regulatory and scientific documentation, including Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans, and Clinical Study Reports.
  • Maintain a working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
  • Develop and maintain relationships with internal and external clients and scientists.
  • Review and author scientific publications, abstracts, and posters.
  • Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating effectively with the team.
  • Summarize and present results to supervisors in a logical manner, verbally and in written reports or presentations.
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 communicating alternatives.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
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. Our salary ranges are determined by role, level, and location. The Canadian base salary range for this full-time position is $94,000 - $, + bonus + equity + 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.

We are an equal opportunities employer and welcome applications from all qualified candidates. We are committed to diversity and inclusion in the workplace and are proud to be an employer of choice for people with disabilities. If you require accommodation during the recruitment process, please let us know and we will work with you to provide a suitable arrangement.

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