Senior Pk/pd Scientist/modeler

il y a 2 semaines


Gent, Belgique Argenx Temps plein

The argenx Quantitative Pharmacology and Pharmacometrics group (QCP²) looks for an experienced PK/PD scientist/modeler to support multiple aspects during pre-clinical drug development.

We envision that the experienced PK/PD scientist/modeler 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/PD scientist/modeler 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/PD scientist/modeler 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 Quantitative Pharmacology and Pharmacometrics.

Key Accountabilities/Responsibilities:
The senior PK/PD scientist/modeler
- 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)

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 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.


  • Senior Biostatistics Scientist

    il y a 4 semaines


    Gent, Belgique BioLizard Temps plein

    Who we are BioLizard is a consultancy company providing bioinformatics, data science and data management solutions for our customers in biotech, pharma and diagnostics. Typically, a lizard adjusts to its surroundings. That is exactly what we do, we adapt to our customers’ data environment! The research field is rapidly becoming more data-driven, where we...


  • Gent, Belgique Argenx Temps plein

    As member of Quantitative Clinical Pharmacology and Pharmacometrics (QCP²), the Clinical Pharmacologist/Pharmacometrician will support aspects of clinical pharmacology and responsible for supervising and conducting population PK/PD modeling and simulation activities with emphasis on both early and late-phase drug development. Principal Responsibilities: -...

  • Senior Scientist Cmc

    il y a 4 semaines


    Gent, Belgique Argenx Temps plein

    1. PURPOSE OF THE FUNCTION A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody...

  • Associate Scientist

    il y a 4 semaines


    Gent, Belgique Exevir Bio Temps plein

    **WE ARE HIRING** **Associate Scientist **THE COMPANY** ExeVir Bio is a young and dynamic pre-clinical stage company, working with a modular platform, developing single-domain antibody-based therapies focused on infectious diseases. ExeVir Bio has set-up a Preclinical Research Laboratory in Gent and we are seeking a highly motivated Associate Scientist...

  • Senior Data Scientist Ai

    il y a 4 semaines


    Gent, Belgique A.C.A. Group Temps plein

    **Senior Data Scientist AI**: **Ons Innovation Lab is op zoek naar een gepassioneerde Data Scientist die samen met ons team onze unit verder vorm wil geven.**: Zie jij deze uitdaging zitten? **Nu al overtuigd om met ons te werken?**: *** **Jouw rol binnen ACA**: **Ons team**: - Je zal als Data Scientist of Machine Learning Engineer onderdeel uitmaken van...


  • Gent, Belgique BASF SE Temps plein

    JOIN THE TEAM Agriculture plays a fundamental role in fulfilling many of humanity's basic needs: food, feed, energy. To support growers and those who take care of our environment, BASF develops innovative solutions for farming, pest- disease- and weed- control and landscape management. Within BASF Seed and Traits R&D, Plant Genome Engineering is embedded in...

  • Data Scientist

    il y a 6 jours


    Gent, Belgique Deliverect Temps plein

    **Deliverect** As a rapidly scaling global SaaS unicorn, Deliverect stands at the forefront of revolutionising technological solutions for the dynamic hospitality and Q-commerce sectors. Our mission is clear: to empower ambitious individuals with the skills and knowledge to make a positive impact on business. Developing in their professional careers, all...


  • Gent, Belgique BioLizard Temps plein

    **Job description **Single cell bioinformatics scientist** **Who are we?** BioLizard is a growing consultancy company providing data science solutions for our customers in biotech and pharma. Typically, a lizard adjusts to its surroundings and that is exactly what we do. At BioLizard we adapt to our customers’ data environment! The research field is...


  • Gent, Belgique Zomagen Biosciences Belgium BV Temps plein

    **Job description and responsibilities** As a full-time scientist in the Discovery Team, your responsibilities include, but are not limited to: - Work collaboratively within your team to develop novel project ideas and offer innovative approaches to scientific questions. - Design and execute (either internally or with an academic/commercial partner) in...

  • Junior Scientist

    il y a 4 semaines


    Gent, Belgique Ardena Temps plein

    **About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...


  • Gent, Flandre, Belgique BASF SE Temps plein

    JOIN THE TEAMAgriculture plays a fundamental role in fulfilling many of humanity's basic needs: food, feed, energy. To support growers and those who take care of our environment, BASF develops innovative solutions for farming, pest- disease- and weed- control and landscape management. Within BASF Seed and Traits R&D, Plant Genome Engineering is embedded in...

  • Senior SAP Ewm Consultant

    il y a 3 jours


    Gent, Belgique Conexus Temps plein

    Conexus are working for a global company who is searching for an experienced Senior SAP EWM Consultant to work on a hybrid basis model with the scope of the project being S/4HANA. **Requirements for this role**: - A minimum of 6 years of experience with SAP EWM - A minimum of 1 full life cycle completed with S/4HANA - Experience with cross module...

  • Senior SAP Ewm Consultant

    il y a 3 jours


    Gent, Belgique ConexusDX Temps plein

    **Job description**: Conexus are working for a global company who is searching for an experienced Senior SAP EWM Consultant to work on a hybrid basis model with the scope of the project being S/4HANA. **Requirements for this role**: - A minimum of 6 years of experience with SAP EWM - A minimum of 1 full life cycle completed with S/4HANA - Experience with...

  • Senior Software Architect

    il y a 4 semaines


    Gent, Belgique 4D vision Temps plein

    **What’s in a name**: Als Senior Software Architect bij 4D vision speel je een essentiële rol in het definiëren, ontwerpen en optimaliseren van onze software-architectuur, terwijl je gebruikmaakt van de nieuwste Microsoft-technologieën. Bovendien werk je nauw samen met onze developers, project managers én klanten om gepersonaliseerde IT-oplossingen op...


  • Gent, Belgique Argenx Temps plein

    For the expansion of the bioanalytical team, argenx is looking for a (Associate) Director Bioanalytics, with profound experience in late-stage drug development of large molecules. The level and title will depend on the experience of the incumbent. He/she will conduct and lead bioanalytical support in all aspects for one of the argenx indication franchises....


  • Gent, Belgique Tractebel Temps plein

    **_Tractebel is a global engineering and consulting company delivering integrated solutions for sustainable energy and built environment projects. Our expertise is trusted worldwide across multiple markets like nuclear, renewables, power & gas, electrical grids, hydropower & dams, water resources & supply, desalination, complex & high-tech buildings,...


  • Gent, Belgique In4Matic Temps plein

    **Function**: We're looking for a Senior Analyst with experience in Functional & Business analysis to join our client's team. You will join a dynamic organization focused on digital transformation across various service domains. This role is a unique opportunity to be at the forefront of shaping digital policy and processes, collaborating with a wide range...

  • Protein Science Leader

    il y a 4 jours


    Gent, Belgique Panda Temps plein

    Job Title: Protein Science Leader Department: Research and Development Reports To: Head of Research and Development Location: Ghent, Belgium Summary: Seeks a visionary Protein Science Leader to spearhead its cutting-edge research initiatives. As a seasoned expert in protein science and structural analysis, you will play a pivotal role in shaping the...


  • Gent, Belgique Retailors Temps plein

    Job title: Back of House Coach (Stock Manager) **_ Are you ready?_** We are currently seeking a Back of House Coach (Stock Manager) for one of our new store location in Ghent. The Coach’s mission is to ensure the success of the store by creating an environment that will provide a premium consumer and employee experience and implementing/executing...

  • Platform Strategy Manager

    il y a 4 semaines


    Gent, Belgique A.C.A. Group Temps plein

    **Platform Strategy manager**: **Word je enthousiast bij het idee de verdere groei van ACA Group te ondersteunen? Heb je ervaring in het definiëren en ontwikkelen van succesvolle platformen?**: Dan ben jij misschien wel de Plaform Strategy manager die wij zoeken! **Nu al overtuigd om met ons te werken?**: *** **Jouw rol binnen ACA**: Als **Platform...