The department of clinical pharmacology, modeling and simulation seeks a motivated, and skilled quantitative scientist who will drive the development and execution of computational modeling and simulation strategies to enable nextgeneration pharmacometric analyses.

We are seeking a subject matter expert with experience in quantitative approaches to inform drug development. Proficiency in one or more of the following areas is highly desirable: applied mathematics, multivariate statistical methods, AI/ML-based modeling and analytics, data warehousing, automation of complex data workflows, data engineering and emerging computing technologies. Knowledge of pharmacokinetic/pharmacodynamic (PK/PD) modeling will be useful.

In this role, the Principal Scientist will contribute across a broad range of activities, including, curation and visualization of complex datasets, developing and industrializing novel computational methods for QSP and PK/PD modeling and automation of pharmacometric workflows. The candidate is also expected to establish, lead and mentor a team of junior scientists to deliver on department objectives.

This role is ideal for a scientific leader with quantitative science background and interest in PK/PD and exposureresponse modeling, who is passionate about integrating quantitative methods, data science, and emerging technologies to influence critical development and regulatory decisions at a global level.

Key responsibilities may include:

- Independently developing and implementing analytics workflows to manage and analyse large, complex datasets from diverse sources, including realworld data.
- Driving innovation through the application of modern data architecture, data science engineering, data modeling, and advanced computing methodologies.
- Planning and executing PK/PD analyses that integrate pharmacokinetics, pharmacodynamics, patient characteristics,



and disease biology to optimize dose selection, dosing regimens, and study designs.
- Mentoring and managing junior scientific staff to support modeling and simulation activities and collaborating closely with other modelers to implement data and modeling workflows for cutting-edge pharmacometric projects.
- Collaborating with crossfunctional partners, including observational research, health economics and outcomes research, statistics, and clinical biostatistics teams, to enable platformlevel analytics and modeling workflows.
- Providing scientific thought leadership, guidance, and strategic input, and contributing to the external scientific community through publications and conference presentations.

Preferred Qualifications:

- Doctorate degree and 8 years of clinical pharmacology experience OR Masters degree and 12 years of clinical pharmacology experience OR Bachelors degree and 15 years of clinical pharmacology experience.

- Degree in Statistical and Data sciences, Computer Science, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees (e.g. MD, PharmD), and experience in the life sciences, Biotechnology and/or Pharmaceutical Industry, consulting or post-doctoral training
- Demonstrated experience with scripting and implementing computational algorithms, optimization and model qualification methods, data analytics algorithms and models.
- Hands on experience using a modeling software (e.g. Python, MATLAB, R, Julia, NONMEM, SAS, S-Plus, SQL, etc).
- Excellent interpersonal, technical, and communication skills to lead cross-functional teams
- Previous record of scientific contributions through peer-reviewed articles and external presentations
- Experience in PK/PD modeling and population-based analyses/simulations with established track-record of model-based drug development in multiple therapeutic areas will be an advantage

📌 Principal Scientist - Clinical Pharmacology, Modeling and Simulation (Hyderabad)
🏢 Amgen
📍 Hyderabad