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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) 

Principal Scientist Pharmacometrics - Hyderabad

 

The Principal Scientist Pharmacometrics position is responsible for the co-development and execution of population pharmacokinetic [PK], pharmacodynamic [PD], and exposure-response (ER) modeling and simulation activities related to the planning, implementation, analysis, interpretation, and reporting for compounds in development. Additional responsibilities include the authoring of pharmacometrics documents related to regulatory submissions, preparing responses to Agency questions and contributing to meetings with Regulatory Agencies and Advisory Committee Meetings.  

The position is responsible for contributing to the development of Model Informed Drug Development (MIDD) plans with guidance from senior members of the group, clinical pharmacology leaders and other stakeholders.  With guidance, the Principal Scientist can execute the day-to-day operations for the pharmacometric analyses of the assigned programs.   

 

Principal Responsibilities:  

Accountabilities with guidance from senior members of the group:    

• Conduct population PK, PD, ER analyses to inform dose regimen selection and other key drug development decisions, support the design of clinical studies and model-informed drug development plans, and to support regulatory submissions. 

• Write analysis plans & reports, define data requirements, conduct analyses, perform quality control (QC) checks, and interpret PK/PD data and results.  

• Work effectively in a matrix environment, managing pharmacometrics deliverables in accordance with timelines and overall project goals.  

• Contribute to the development of new methodology and/or applications of pharmacometrics.  

 
Other Accountabilities & Tasks:  

• Present internally and at external scientific meetings; prepare and publish manuscripts in peer reviewed scientific journals; may participate in special interest groups within professional societies.  

• Assist in process improvement initiatives, software validation and other technology improvements.  

• Carry out functional responsibilities in accordance with applicable SOPs, departmental processes and Regulatory requirements, and Johnson & Johnson Credo principles.  

 

Education and Experience Requirements:   

• Ph.D. degree or equivalent in Pharmaceutical Sciences, Pharmacometrics, Chemical/Biomedical/Bio- Engineering or Biological Sciences, with 2+ years of post-doctoral experience or M.S. degree with 4+ years of relevant experience. 

 

Minimum Technical Knowledge and Skills: 

• Working knowledge of PK & PK/PD modeling and simulation (pharmacometrics) concepts and methods. 

• Hands-on knowledge of pharmacometrics modeling software (NONMEM and/or Monolix, R).  

• Understanding of the overall drug development process including MIDD and the Pharmaceutical R&D process. 

• Working knowledge of regulatory requirements and guidelines. 

• Good oral and written communication skills. 

 

Other:  

• Estimated both domestic and international travel of about 5% of time.   

 

 

 

 

Required Skills:

 

 

Preferred Skills:

Clinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Consulting, Critical Thinking, Drug Development, Drug Discovery Development, Organizing, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research