Senior Manager – Clinical Pharmacology Modeling & Simulation
Company: Amgen
Location: Hyderabad, Telangana, India
Job Type: Full-Time | On-Site
Experience: 12–15 Years (Clinical Pharmacology / PK-PD Analysis)
Qualification: Master’s or Bachelor’s Degree in Pharmacy, Biology, Chemistry, Biochemistry, or related field
Approx Salary: ₹40 LPA – ₹70 LPA
Job Overview
Amgen is seeking a Senior Manager – Clinical Pharmacology Modeling & Simulation to support clinical pharmacology data analysis for its drug development programs.
The role focuses on pharmacokinetic and pharmacodynamic (PK/PD) analysis, clinical study reporting, and modeling activities to support regulatory submissions and clinical decision-making. The position also includes team leadership responsibilities, overseeing analysts and ensuring high-quality data analysis and reporting.
Key Responsibilities
1. PK/PD Data Analysis
Conduct clinical pharmacology data analyses including non-compartmental analysis (NCA).
Analyze and interpret pharmacokinetic and pharmacodynamic datasets from clinical studies.
Ensure accurate generation of tables, figures, and listings (TFLs) for study reports.
2. Clinical Study Reporting
Prepare and review clinical pharmacology sections of clinical study reports (CSRs).
Summarize PK/PD results and study outcomes for regulatory and internal documentation.
Maintain high standards of scientific accuracy and data integrity.
3. Team Leadership & Mentoring
Manage and train clinical pharmacology data analysts.
Review work outputs from team members to ensure quality, consistency, and regulatory compliance.
Support career development and technical skill growth within the team.
4. Cross-Functional Collaboration
Work closely with Clinical Pharmacology Modeling & Simulation (CPMS) teams and other project stakeholders.
Collaborate with clinical development, regulatory, and biostatistics teams.
Communicate technical findings and analysis results to project teams.
5. Compliance & Quality Assurance
Ensure all analyses follow Good Clinical Practice (GCP) guidelines and company SOPs.
Maintain compliance with regulatory standards and internal quality processes.
Conduct quality control checks on datasets and analysis outputs.
Required Skills
Technical Skills
Strong expertise in pharmacokinetics and pharmacodynamics (PK/PD)
Experience performing non-compartmental analysis (NCA)
Experience working with clinical pharmacology datasets
Familiarity with Phoenix PK/PD modeling software
Knowledge of SAS ADaM datasets for clinical analysis
Soft Skills
Leadership and team management
Strong analytical and problem-solving ability
Effective written and verbal communication
Ability to work under tight timelines in global project teams
Preferred Qualifications
Degree in Pharmacy or Life Sciences (Biology, Chemistry, Biochemistry)
Strong understanding of drug development processes and clinical pharmacology studies
Experience with regulatory guidelines and GCP standards
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint)
Key Competencies
Clinical pharmacology data analysis
PK/PD modeling and simulation
Clinical study reporting and regulatory documentation
Team leadership and mentoring
Cross-functional collaboration in global pharmaceutical programs
About the Company
Amgen is a global biotechnology leader focused on developing innovative therapies for serious illnesses. Since its founding in 1980, the company has been dedicated to advancing medicine through biological research, genetic insights, and cutting-edge drug development.
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