Senior Manager – Clinical Pharmacology Modeling & Simulation | Hyderabad, India
Location: Hyderabad, India
Job Type: Full-Time
Work Mode: On-site
Amgen is hiring a Senior Manager – Clinical Pharmacology Modeling & Simulation in Hyderabad, India to support clinical pharmacology research and drug development activities. This role focuses on pharmacokinetic/pharmacodynamic (PK/PD) data analysis, clinical pharmacology modeling, non-compartmental analysis (NCA), and regulatory-compliant clinical study reporting. It is ideal for experienced professionals in clinical pharmacology, pharmacometrics, SAS analytics, and pharmaceutical research who can lead teams and manage pharmacology data analysis for clinical studies.
The Senior Manager will oversee clinical pharmacology data analysis activities while managing and mentoring team members responsible for PK/PD analysis, dataset review, and clinical study report preparation. The role involves collaborating with cross-functional research teams and ensuring all analyses follow regulatory standards, Good Clinical Practices (GCP), and internal SOPs. Candidates with strong expertise in clinical pharmacology datasets, Phoenix analysis software, SAS ADaM datasets, and drug development processes will be well suited for this position.
💰 Expected Salary (Approx.)
For Senior Manager – Clinical Pharmacology / Pharmacometrics roles in multinational pharmaceutical companies in India, the estimated salary range is:
₹40 LPA – ₹60 LPA (Estimated)
Compensation may vary based on:
Total experience in clinical pharmacology or pharmacokinetic/pharmacodynamic analysis
Leadership experience managing clinical pharmacology or pharmacometrics teams
Expertise in non-compartmental analysis (NCA), PK/PD modeling, and pharmacometric tools
Experience with Phoenix software, SAS ADaM datasets, and regulatory submissions
Academic qualifications such as Master’s or advanced degrees in Pharmacy, Pharmacology, or Life Sciences
Global biotechnology companies like Amgen typically offer competitive salary packages along with leadership opportunities in clinical pharmacology research and drug development programs.
Job Summary
The Senior Manager – Clinical Pharmacology Modeling & Simulation will play a critical role in supporting Amgen’s multimodality drug development portfolio by conducting and supervising PK/PD data analysis and clinical pharmacology research. The role involves analyzing pharmacokinetic and pharmacodynamic data, preparing analytical outputs, and ensuring accurate reporting in clinical study reports and regulatory submissions.
You will lead a team of analysts responsible for conducting formal PK/PD analyses, data quality control, and report writing, ensuring the results meet scientific and regulatory standards. The role also requires close collaboration with clinical pharmacology modeling and simulation teams, research scientists, and project stakeholders to support drug development programs across multiple therapeutic areas.
Key Responsibilities
Manage and mentor team members performing PK/PD data analysis and report writing
Review tables, figures, listings, and analysis outputs generated by team members
Conduct formal pharmacokinetic and pharmacodynamic data analyses
Perform non-compartmental analysis (NCA) for clinical pharmacology studies
Ensure quality control and consistency of clinical pharmacology data outputs
Prepare and review clinical study reports and regulatory documentation
Collaborate with clinical pharmacology modeling and simulation teams
Communicate analysis results to project teams and cross-functional stakeholders
Ensure compliance with Good Clinical Practices (GCP) and regulatory guidelines
Maintain adherence to company SOPs and internal processes
Required Skills & Qualifications
Master’s degree with 12+ years of experience in clinical pharmacology data analysis
OR
Bachelor’s degree with 15+ years of relevant experience
Required expertise includes:
Strong knowledge of clinical pharmacology and PK/PD concepts
Experience conducting non-compartmental pharmacokinetic analysis
Experience working with clinical pharmacology datasets
Experience writing clinical study analysis reports
Strong analytical, communication, and teamwork skills
Ability to manage complex projects and meet strict timelines
Preferred Skills
Degree in Pharmacy, Pharmacology, Biology, Chemistry, or Biochemistry
Experience managing teams and supporting career development
Experience using Phoenix pharmacokinetic analysis software
Knowledge of standardized SAS ADaM datasets
Familiarity with drug development processes and regulatory guidelines
Strong skills in Microsoft Office tools (Word, Excel, PowerPoint)
Ability to work effectively within global cross-functional teams
Benefits & Career Opportunities
Leadership role in clinical pharmacology and drug development research
Opportunity to work on multimodality therapeutic programs
Collaboration with global experts in pharmacology, modeling, and simulation
Career growth within biotechnology R&D and clinical development teams
Opportunity to contribute to innovative therapies that improve patient outcomes
About the Company
Amgen is a leading global biotechnology company dedicated to discovering, developing, and delivering innovative medicines for serious diseases. With over 40 years of scientific innovation, Amgen uses advanced biology, genetics, and data science to develop therapies that address critical unmet medical needs.
The company continues to lead advancements in biotechnology research, clinical development, and biologic therapeutics, helping improve and extend the lives of millions of patients worldwide.
How to Apply
If you have strong experience in clinical pharmacology data analysis, PK/PD modeling, pharmacometrics, or pharmaceutical research, this role provides an opportunity to lead analytical teams and contribute to drug development programs that advance innovative treatments.
Apply now to join Amgen’s Clinical Pharmacology Modeling & Simulation team and help drive the development of next-generation therapies.
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