Scientist Pharmacometrics Support - Hyderabad

Johnson & Johnson Innovative Medicine; Hyderabad; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Hyderabad seeks a Scientist Pharmacometrics Support to provide technical and operational support for PK/PD modeling and data submissions. The role focuses on dataset assembly, QC, and regulatory e-submission packages with oversight from senior staff.

You will work across CPP, ensuring timely, compliant trials and submissions, while contributing to process improvements and global regulatory readiness in a multidisciplinary team.

Qualifications

• 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.

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 validationandother technology improvements
• Carryout functional responsibilitiesin accordance withapplicable SOPs, regulatoryrequirementsand Johnson Credo principles.

Skills

Analytical Reasoning

Clinical Pharmacology

Pharmacokinetic Modeling

Pharmacokinetics

Pharmacometrics

Regulatory Environment

Data Savvy

Detail-Oriented

Study Management

Execution Focus

Drug Discovery Development

Relationship Building

Report Writing

Scientific Research

Technologically Savvy

Education

Bachelor’s degree in a scientific discipline

Tools

R

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 validationandother technology improvements
• Carryout functional responsibilitiesin accordance withapplicable SOPs, regulatoryrequirementsand 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