Are you an experienced scientist with expertise in Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modelling (PBBM)? We are looking for a highly motivated Senior Scientist to support the development and optimization of innovative drug products across all stages of development.
In this role, you will apply mechanistic modelling and simulation approaches to predict and understand the impact of drug substance properties, formulation design, physiology, and clinical variables on in vivo performance and patient outcomes. You will collaborate with multidisciplinary teams to support model-informed drug development and regulatory decision-making.
Key Responsibilities:
- Develop, verify, and apply PBBM and PBPK models using industry-standard software platforms.
- Predict and assess oral absorption, food effects, bioavailability, formulation bridging, dissolution and particle size specifications, and virtual bioequivalence.
- Perform model calibration, sensitivity analyses, scenario testing, and uncertainty assessments to support development decisions.
- Collaborate with laboratory scientists to design and interpret in vitro studies supporting model development and verification.
- Support the development of clinically relevant dissolution methods and in vitro-in vivo relationships.
- Communicate modelling outcomes through technical reports, presentations, regulatory documents, and scientific publications.
- Contribute to innovations in modelling methodologies, automation, and AI/ML-driven predictive approaches.
Required Qualifications;
- PhD or MSc in Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics, Pharmacometrics, Chemical Engineering, or a related discipline.
- Demonstrated expertise in PBPK, PBBM, pharmacometrics, mechanistic modelling, or model-informed drug development.
- Strong understanding of oral absorption, dissolution, permeability, biopharmaceutics, and pharmacokinetics.
- Experience with modelling software such as Simcyp, GastroPlus, PK-Sim, or equivalent platforms.
- Proven ability to apply modelling approaches to solve pharmaceutical development challenges.
- Excellent scientific communication and stakeholder engagement skills.
Preferred Qualifications;
- Experience supporting regulatory submissions involving PBPK or PBBM analyses.
- Experience with virtual bioequivalence and clinically relevant dissolution specifications.
- Programming experience with Python, R, MATLAB, or similar scientific tools.
- Knowledge of machine learning and data science applications in pharmaceutical development.
- Experience across a range of drug modalities, including poorly soluble compounds, enabling formulations, peptides, or complex dosage forms.
Senior Scientist, Biopharmaceutics Modelling & Simulation (PBBM/PBPK) employer: SRG
As a Senior Clinical Trial Manager at our company, you will thrive in a dynamic and collaborative work environment that prioritises innovation and employee development. We offer competitive benefits, a strong focus on professional growth, and the opportunity to work alongside industry leaders in a location renowned for its commitment to advancing clinical research. Join us to make a meaningful impact in the field of clinical trials while enjoying a supportive culture that values your contributions.
