Principal Scientist - Clinical Pharmacology, Modeling and Simulation

Amgen Inc. (IR); Hyderabad; On-site; INR 4,500,000 - 7,500,000; Full time

Job summary

Amgen Inc. in Hyderabad, India, seeks a Principal Scientist to lead quantitative pharmacometric work across PK/PD modeling, data science, and automation of workflows.

You will mentor junior scientists, develop novel computational methods, and collaborate with cross-functional teams to influence development decisions at a global level.

Qualifications

• PhD or higher in a life-science or data-science field with pharmacology exposure.
• Strong scripting and computational algorithm experience; model-based drug development background.
• Experience leading cross-functional teams and publishing in peer-reviewed venues.

Responsibilities

• Develop analytics workflows to analyze large, diverse data sources including real-world data.
• Plan and execute PK/PD analyses to optimize dose selection and study designs.
• Mentor junior scientists and collaborate with modelers to implement workflows.
• Collaborate with observational research, health outcomes, statistics, and biostatistics teams.
• Provide scientific leadership and contribute to external publications.

Skills

Python

MATLAB

R

Julia

NONMEM

SAS

SQL

PK/PD modeling

Data visualization

Education

Doctorate degree in Statistical/Data sciences or related field

Tools

Python

MATLAB

R

Julia

NONMEM

SAS

SQL

S-Plus

Job description

Career Category Research Job Description

About AMGEN

Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.

ABOUT THE ROLE

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 next-generation 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 exposure-response 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 real-world 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 innovative pharmacometric projects.
• Collaborating with cross-functional partners, including observational research, health economics and outcomes research, statistics, and clinical biostatistics teams, to enable platform-level 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 Master's degree and 12 years of clinical pharmacology experience OR Bachelor's 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

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request an accommodation. .

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen