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Scientist, Clinical Pharmacokinetics Specialist
2 months ago
Zymeworks is seeking a highly skilled Clinical Pharmacokinetics Specialist to join our team. As a key member of our Clinical Pharmacology group, you will be responsible for analyzing and interpreting clinical pharmacokinetic data to support the development of our therapeutic molecules.
Key Responsibilities- PK Data Analysis: 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.
- Team Collaboration: Represent Clinical Pharmacology line function and work 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.
- Reporting and Documentation: Independently analyze, interpret, and report clinical PK data as a member of several multidisciplinary development program teams. Write and review relevant sections of regulatory and scientific documentation, including Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans, and Clinical Study Reports.
- Modeling and Simulation: Work with clinical teams to design PK components in various study designs, such as first-in-human and drug-drug interaction studies. Develop and maintain a working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
- Communication and Collaboration: Develop and maintain relationships with internal and external clients and scientists. Review and author scientific publications, abstracts, and posters. Present results to supervisors and project teams in a logical and clear manner.
- Project Management: Work closely with SAS programmers and Clinical Operations to ensure deliverables are completed in a timely and efficient manner. Accountable for ensuring appropriate PK-PD analysis, including population PK, PK-PD modeling and simulation, exposure-response analysis, etc.
- Education: PhD or equivalent in Pharmacology/Biomedicine/Biochemistry or related scientific discipline.
- Experience: Minimum 3-5 years of relevant experience within a pharmaceutical industry, contract research, or clinical research. Solid PK training and experience is a must.
- Skills: Proficiency using Phoenix WinNonlin for non-compartmental analysis. Hands-on experience with clinical pharmacology-related work experience in regulatory and scientific documentation writing. Advanced spreadsheet skills are desirable. Familiarity with PK, ADA, and NAb bioanalytical methods development and validation is an asset.
- Personal Qualities: 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. Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
Zymeworks offers a comprehensive total rewards package, including 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
- Zymeworks 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