Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Join Us as Principal Pharmacokineticist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in clinical pharmacology.
You will guide design of nonclinical studies (PK, TK, PKPD), translational PKPD analysis in collaboration with the clinical Pharmacologist, support the bioanalytical scientist in strategic and operational planning of nonclinical and early clinical work.
What You'll Do:
Is responsible for managing and safeguard nonclinical PKPD data
Interacts and discusses data and strategies with stakeholders and vendors for PKPD analysis
Advises and sets up adequate software infrastructure in collaboration with IT
Discusses development strategies with technical and cross-functional teams and advises on design of nonclinical studies including GLP toxicology studies
Reviews study reports including Toxicokinetic phase reports
Processes and models data using appropriate software (such as Phoenix WinNonlin, R)
Reports results to nonclinical pharmacology and bioanalytical team, cross-functional teams and argenx management
Prepares documents to a quality standard required for Regulatory/Health Authority submissions
Interacts with internal stakeholders to understand different project requirements and ensures timely, open and effective communication to relevant stakeholders (teams, collaborators, management)
Applies model informed drug development (MIDD)
Education and Experience Requirements:
Advanced degree (Master or PhD) in a scientific discipline with a strong mathematical component or equal by experience
PKPD modelling experience in translational and early phases of development. Experience in different disease areas is a plus
Knowledge, Skills and Abilities:
Basic understanding of GLP requirements for nonclinical safety studies
Knowledge of regulatory requirements to characterize the nonclinical pharmakinetics and safety of new biologic entities and how to propose and justify human starting doses
Strong communication skills
Strong collaborative and interpersonal skills
Problem solving skills
Able to motivate external teams
Flexible; Deal with continuous change
Fluent in English
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.