Senior Associate - Clinical Pharmacology

Amgen Inc. (IR); Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amgen Inc. (IR) in Hyderabad seeks a Senior Associate in Clinical Pharmacology, Modeling and Simulation to conduct formal PK/PD data analyses, summarize results for clinical study reports, and support data quality control within CPMS.

The role requires a Master’s degree with 5 years of related experience or a Bachelor’s with 7 years, strong writing and communication skills, teamwork, and adherence to GCP and SOPs; Phoenix, ADaM experience highly valued.

Qualifications

• Master’s degree with 5 years of clinical pharmacology data analysis experience focused on non-compartmental analysis.
• Bachelor’s degree with 7 years of relevant experience in clinical pharmacology data analysis.
• Experience with regulatory guidelines (GCP) and report writing.

Responsibilities

• Execute formal PK/PD data analyses and write clinical study reports with high quality and timeliness.
• Perform quality control of analyses, tables, figures, listings and reports.
• Review and create standardized datasets supporting clinical pharmacology analyses.
• Collaborate cross-functionally with CPMS data analysts and project teams.

Skills

Pharmacokinetic analysis

Non-compartmental analysis

PK/PD data analysis

Regulatory guidance (GCP)

Phoenix software

ADaM datasets

Publication/report writing

MS Office

Education

Master’s degree in Clinical Pharmacology

Bachelor’s degree in Pharmacy

Tools

Phoenix Analysis Software

ADaM datasets

Job description

Career Category Clinical 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.

Primary Core Responsibilities

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

Basic Qualifications

• 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:

• good understanding of clinical pharmacology and pharmacokinetic/pharmacodynamic concepts
• experience in conducting non-compartmental analysis
• experience working with clinical pharmacology datasets and report writing
• 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

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