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.
Post : Senior Associate - Clinical Pharmacology
Job Description
The department of Clinical Pharmacology, Modeling and Simulation (CPMS) within Amgen is dedicated to the development of novel, effective, and safe medicines. We are seeking a highly experienced Senior Associate to join the CPMS group.
The successful candidate will contribute to Amgen’s multimodality development portfolio by conducting formal clinical pharmacology data analyses, summarizing pharmacokinetic/pharmacodynamic (PK/PD) data and results in clinical study report documents, performing quality control, reviewing PK/PD datasets, and adhering to applicable regulatory guidance (ie, good clinical practices [GCP]). In addition, the successful candidate will possess good written and oral communication skills, the ability to work well in teams, and will demonstrate technical aptitude and a strong work ethic. The individual will also be responsible for review and compliance with all applicable SOPs, business practices and company policies.
The primary core responsibilities of the Senior Associate will include :
• Execution of formal PK/PD data analysis and report writing for clinical studies with a strong emphasis on quality and meeting timelines
• Perform quality control of analyses and outputs (ie, tables, figures, listings, and reports) to ensure accuracy and consistency in accordance with standard processes
• Review and create standardized datasets supporting clinical pharmacology analyses
• Work closely with CPMS data analysts and other team members, effectively communicate with project team representatives and actively participate/collaborate cross functionally
Candidate Profile
Master’s degree and 5 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis
OR
Bachelor’s degree and 7 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis
Preferred Qualifications
• Bachelor’s or Master’s degree in Pharmacy preferred, but can also be in related fields such as biology, chemistry, or biochemistry.
• Following skills are required:
o good understanding of clinical pharmacology and pharmacokinetic/pharmacodynamic concepts
o experience in conducting non-compartmental analysis
o experience working with clinical pharmacology datasets and report writing
o experience in working with Phoenix analysis software and with standardized analysis datasets (ADaM)
• Familiar with the drug development process, regulatory guidelines (including Good Clinical Practices), analysis methodology, and clinical pharmacology studies
• Skilled in using Microsoft Office software (ie, Word, Excel, PowerPoint)
• Able to work under tight deadlines
• Strong analytical, writing, communication, organization, and teamwork skills
Additional Information
Experience : 5+
Qualification : Master’s degree OR Bachelor’s degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Pharmacology
End Date : 30th September 2026
Senior Associate : Apply Online
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