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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmacokinetics & Pharmacometrics

Job Category:

Scientific/Technology

All Job Posting Locations:

Hyderabad, Andhra Pradesh, India

Job Description:

Clinical Pharmacology & Pharmacometrics (CPP)

Scientist Pharmacometrics Support - Hyderabad

 

Position Summary:

The Scientist, Pharmacometrics Support, provides technical and operational support to Clinical Pharmacology & Pharmacometric leaders in the execution of PK, PD, and PK/PD modelling and simulation activities across all therapeutic areas. The role focuses on data assembly, dataset quality control, and regulatory e‑submission support, ensuring timely, compliant, and high‑quality trial and submission deliverables in accordance with CPP standards and global regulatory requirements with oversight of a senior Pharmacometrics Support Programmer

This role supports trial and submission deliverables post‑interim and final database release, applies established CPP processes, and contributes to continuous process improvement within CPP.

Principal Responsibilities:

• Support CPP trial deliverables across all therapeutic areas, primarily post‑interim and final database release, by preparing analysis‑ready datasets for PK and/or PD analyses (ADNCA & NONMEM).
• Perform basic Pharmacometrics analysis QC activities, including documentation of QC checks, findings, and follow‑up actions.
• With oversight, support global regulatory submissions by preparing population PK/PD & Exposure Response e‑submission packages, including datasets, control files, outputs, tables, and supporting documentation.
• Assists in process improvement initiatives, software validation and other technology improvements
• Carry out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles. 

Principal Relationships:

 

Internal: CPP Clinical Pharmacology & Pharmacometrics Leaders, CPP Scientists, Data Management, Clinical & Statistical Programming, Bioanalysis (BDDS), Regulatory & Publishing teams.

External: PK office vendors and other external stakeholders.

Education and Experience Requirements:

 

Bachelor’s degree (or equivalent) in a scientific discipline

1–3 years of experience in the pharmaceutical industry, preferably within Clinical Pharmacology, Pharmacometrics, or data analysis support roles

Minimum Technical Knowledge and Skills

• Basic proficiency in R for data manipulation
• Basic understanding of SDTM and ADaM clinical data structures
• Basic understanding of ADNCA & NONMEM input dataset requirements
• Good understanding of:
  • Non‑linear mixed‑effects modeling
  • Clinical PK and PK/PD concepts
  • Clinical drug development processes

Minimum Non‑Technical Competencies and Skills

• Clear written and verbal communication skills
• Strong attention to detail and quality mindset
• Ability to work effectively in cross‑functional teams
• Effective planning, prioritization, and multitasking skills
• Accountability for timely delivery of assigned tasks
• Continuous learning mindset and openness to process improvement
• Cultural awareness and ability to work in global teams
• Ability to work independently with oversight

 

Other:

Language requirements: fluent in English, local language requirements as applicable.

Travel: Approximately 5%

 

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Clinical Data Management, Clinical Operations, Clinical Pharmacology, Data Savvy, Detail-Oriented, Drug Discovery Development, Execution Focus, Pharmacokinetic Modeling, Pharmacokinetics, Pharmacometrics, Regulatory Environment, Relationship Building, Report Writing, Scientific Research, Study Management, Technologically Savvy