Senior Manager - Clinical Pharmacology Modeling & Simulation

Location: India - Hyderabad

Remote Type: On Site

Time Type: Full time

Job Description

Career Category

Job Description

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, adhering to applicable regulatory guidance (ie, good clinical practices [GCP]), and providing oversight of clinical pharmacology data analysts performing similar tasks.  In addition, the successful candidate will possess good written and oral communication skills, the ability to work well in teams, 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 Manager will include:

• Manage and train direct reports performing formal PK/PD data analysis, report writing, and quality control of clinical studies
• Review analyses and outputs (ie, tables, figures, listings, and reports) of direct reports performing PK/PD data analyses on clinical studies to ensure accuracy and consistency in accordance with standard processes
• Execution of formal PK/PD data analysis and report writing for clinical studies with a strong emphasis on quality and meeting timelines
• Work closely with CPMS and other team members, effectively communicate with project team representatives and actively participate/collaborate cross functionally

Basic Qualifications

Master’s degree and 12 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis

OR

Bachelor’s degree and 15 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 or related fields such as biology, chemistry, or biochemistry.
• Following skills are required:
  • experience in people management and career development
  • 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 SAS (ADaM) datasets
• 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