Senior PK Scientist

☞ argenx

見る: 160

更新日: 26-11-2025

場所: Ghent East Flanders

カテゴリー: R & D IT-ソフトウェア

業界:

レベル: Associate

ジョブタイプ: Full-time

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仕事内容

The argenx PharmTox-BA group looks for an experienced PK scientist to support multiple aspects during drug development. The team conceives and manages studies that are conducted to assess nonclinical safety and pharmacology of argenx development candidates. In addition, the team develops, qualifies, supports validates and monitors execution of various bioanalytical assays in support of nonclinical and clinical work.

We envision that the experienced PK scientist will guide us in the pre-clinical development strategy of projects, ensuring a high quality data package supportive of human dose selection for first-in-human studies as well as in optimal study design of nonclinical studies based on modelling. Together with the scientists responsible for the study, the PK scientist interprets study outcomes, translates nonclinical PK(PD) to the clinical situation and supports the bioanalytical scientist in strategic and operational planning of nonclinical and early clinical work. These will include setting of desired assay limits, optimized sampling timepoints, expected drug concentrations and consequently expected sample work up.

The senior PK scientist participates in project and technical group meetings, including cross-functional team meetings. He or she will interact with project scientists, bioanalytical experts, GLP study monitors and the clinical pharmacologist/pharmacometrician. He/she will report to the head of toxicology and nonclinical pharmacology.

Key Accountabilities/Responsibilities

The senior PK scientist
  • Will identify PK liabilities in preclinical candidates
  • Is responsible for managing and safeguard PKPD data, including follow up or performing NCA and/or Model-based analysis.
  • Discusses PKPD related development strategies enabling dose selection in FIH studies , through interaction with stakeholders and vendors
  • Advises on design of nonclinical studies including GLP toxicology studies. Reviews study reports including Toxicokinetic phase reports
  • Presents strategies and study 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)
  • Will apply Model-informed-drug-development (MIDD) principles throughout the drug development process
Desired Skills And Experience
  • Advanced degree (Master or PhD) in a scientific discipline with a strong mathematical component or equal by experience
  • At least 5 years of PK experience in translational and early phases of development. Experience in different disease areas is a plus.
  • Basic understanding of requirements for NCA of GLP nonclinical safety studies
  • Excellent knowledge in the pharmacokinetics of mAb based therapeutics and solid understanding of translational sciences
  • Experience in the analysis of preclinical or clinical data with common software packages (e.g. WinNonlin/Phoenix or others). Understanding of population modeling for analyzing PK/PD data is a plus
  • Knowledge of regulatory requirements to characterise the nonclinical pharmacology 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.
Offer
  • A competitive salary package with benefits;
  • A work environment in a human-sized, dynamic, rapidly growing biotech company.
Job Info
  • Type: Full time
  • Location: Gent
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締切: 10-01-2026

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