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Job Description:

We are searching for a talented Principal Scientist pharmacokinetic/pharmacodynamic modeling expert in Translation Pharmacokinetic Pharmacodynamic and Investigative Toxicity (TPPIT) group within Preclinical Safety and Translational Sciences (PSTS), to be located in Beerse, Belgium.

The successful candidate will be employed within our PBPK/PD modelling team in TPPIT.

Key responsibilities:

• Represent PSTS/TPPIT as pharmacokinetic/pharmacodynamic modelling expert in cross-functional project teams and external collaborations
• Independently, develop and apply PBPK/PD models to explore the effects of target and pathway modulation, defining candidate drug target profiles and projection of human exposure profiles.
• Predict human dose and regimen, contribute to exposure and pharmacodynamic biomarker-based decision-making for early clinical trials.
• Interpret and communicate modelling results and impact to project teams
• Designs, conducts, interprets and prepares study and regulatory summaries of PBPK and PKPD M& S activities
• Prepare PBPK and/ PKPD M& S-based strategies to support discovery and development programs
• Drive learning through back-translation of clinical exposure and pharmacodynamic data, offering strategic options for future clinical testing.
• Acts as a main contact for team members in discussions relating to the design of their studies and data analysis to support, clinical candidate selection, development and approval of medicines
• Guides junior colleagues through consultation and mentoring in techniques and processes, and provides functional (matrix) supervision

You will be encouraged to have a desire for learning and innovation, and to continue career development through participation in internal and external scientific meetings, and increase visibility for self, J& J IM R& D, and J& J through publications, participation in external organizations, and presentations at major scientific, industry, and regulatory meetings.

Qualifications / Requirements:

Required:

• PhD in a relevant life science subject area, e.g. pharmaceutical sciences, pharmacometrics, computational biology, chemical/biomedical engineering, or a related field
• In-depth training and hands-on experience with PBPK/PKPD analysis and a proven track record to work with different modelling tools (e.g. Monolix, Matlab, Phoenix, GastroPlus, SimCYP or similar platforms)
• Broad understanding and shown interest in various DMPK relevant areas such as physicochemical properties, drug metabolizing enzyme & transporter kinetics
• Excellent written and oral communication skills in English, excellent interpersonal skills, a high level of organizational ability, attention to detail, and flexibility to work effectively in a collaborative environment globally (US and EU) is required.
• Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies

Preferred:

• A minimum of 6 years of pharmaceutical/biotech industry experience supporting discovery/development projects.
• Experience with broader mechanistic modelling frameworks such as QSP.
• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and ability to critically evaluate, interpret and integrate large datasets and literature.