InSilicoMinds
Website:
insilicominds.com
Job details:
We are seeking a Senior PBPK Modeler to join our growing Modeling & Simulation team to support in silico projects across oral, modified-release, and complex drug products.
This is a hands-on scientific role focused on regulatory-grade model development, working closely with modelers and project leads to deliver high-impact in-silico evidence for drug development and regulatory decision-making.
You will play a critical role in scaling our PBPK capability and supporting multiple concurrent programs as project demand continues to grow.
Key Responsibilities
PBPK Modeling & Simulation
• Hands on expereince in Develop, calibrate, and validate PBPK models for small molecules and metabolites using PK-Sim / MoBi (preferred) or equivalent platforms
• Support oral IR, MR/ER, and complex formulations, including metabolite kinetics and accumulation risk
• Perform scenario simulations (dose, formulation, population, DDIs, food effect, steady-state exposure)
• Integrate in vitro data (solubility, permeability, dissolution, enzyme kinetics) into mechanistic models
IVIVR / IVIVC Support
• Contribute to IVIVR and IVIVC strategies linking dissolution, absorption, and systemic exposure
• Support formulation design space exploration using PBPK-led approaches
• Assist in virtual screening of formulation or release profiles where applicable
Regulatory & Scientific Deliverables
• Generate regulatory-quality reports, model descriptions, and justification documents
• Support MIDD-aligned submissions, briefing documents, and scientific responses
• Ensure modeling work meets internal quality, traceability, and documentation standards
Cross-Functional Collaboration
• Work closely with senior PBPK modelers, formulation scientists, and project managers
• Support internal knowledge transfer and scientific discussions
• Assist in mentoring junior team members as the group scales
Required Qualifications
• Advanced degree (MS / PhD) in Pharmaceutics, Pharmacokinetics, Pharmaceutical Sciences, Chemical Engineering, or related field
• Strong hands-on experience with PBPK modeling
• Practical experience using PK-Sim / MoBi (strongly preferred) or equivalent PBPK platforms
• Solid understanding of ADME, biopharmaceutics, and clinical pharmacokinetics
• Experience integrating in vitro, preclinical, and clinical data into mechanistic models
• Ability to independently execute modeling tasks with minimal supervision
Preferred / Nice-to-Have
• Experience with modified-release / extended-release formulations
• Exposure to IVIVC / IVIVR development
• Familiarity with regulatory expectations (FDA / EMA) for PBPK and MIDD
• Experience supporting regulatory submissions or scientific advice meetings
• Programming/scripting exposure (R, MATLAB, Python) is a plus but not mandatory
What We’re Looking For
• Strong scientific reasoning and problem-solving skills
• Comfortable working in a fast-growing, multi-project environment
• Detail-oriented with a focus on scientific rigor and regulatory defensibility
• Collaborative mindset and willingness to support team growth
Why Join Us
• Work on high-impact PBPK and IVIVR/IVIVC programs across diverse drug products
• Exposure to regulatory-grade, real-world modeling challenges
• Opportunity to grow into technical leadership as the team scales
• Be part of a team where in-silico modeling directly drives development and regulatory decisions
Click on Apply to know more.
