Scientist, Pharmacokinetics and Pharmacometrics - Hyderabad

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:
Scientist, Pharmacokinetics and Pharmacometrics - Hyderabad

Position Summary:

The Clinical Pharmacology (CP) PK Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for (in collaboration with the Clinical Pharmacology Leader), the following activities of end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1 studies including: protocol development, pharmacokinetic/pharmacodynamic data analyses, and generating the in-text tables, figures and PK/PD attachments for Clinical Study Reports (CSR) and CP CSR section writing, as well as study summary contributions to CTD documents.

Additional responsibilities include the support of all other studies in any phase of development which include noncompartmental analyses (and all associated activities).

Principal Responsibilities:

• For Phase 1 clinical pharmacology trial protocols, author the CP sections of the protocol, coordinate the overall development of the protocol, and ensure timely approval and issuance of the document.

• Provide QC review of protocols written by others, including other PK Scientists.

• Review non-compartmental analysis (NCA) trial specific data transfer agreements (tsDTA) for the creation of PK/PD analysis datasets.

• Create the Clinical Pharmacology Analysis Plan based on the protocol.

• Perform pre-database lock, interim, and final NCA for trials in all phases of drug development.

Prepare the final NCA output including in-text tables and graphs (and PK/PD attachments) for the CSR.

• Create a logbook with data handling rules for review by the Clinical Pharmacology Leader prior to conducting the final analysis.

• Perform QC for analyses performed others, including other PK Scientists.

• Develop the CP sections of CSR for trials, and facilitate a timely review and approval of those sections.

• Perform CP section CSR review and QC for other PK Scientists.

• For regulatory sub...