PK Scientist

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

Purpose: 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).

You will be responsible for:

Accountabilities with assistance from senior members of the group:

 • For clinical trial protocols under the ownership of CPP, author the CP sections of the protocol, coordinate the overall development of the protocol, and ensure timely approval and issuance of the document.

If necessary, performs review and QC of the protocol.


* For clinical trial protocols under the ownership of the therapeutic area (i.e., Translational Medicine, etc.) where there is serial PK/PD sampling and where non-compartmental analysis (NCA) is required, participate in the development and review of the CP sections of the document.


* If necessary, participate in protocol training of PK/PD-related procedures for clinical study center personnel (i.e., SIV).

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

• Review trial specific data transfer agreements (tsDTA) provided by the PK Office Vendor for the creation of PK/PD analysis datasets.

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

• Performs pre-DBL, interim, and final PK/PD NCA for trials in all phases of drug development.

Prepares final NCA output in tables and graphs for the Clinical Study Report [CSR], and if necessary, internal and external departmental data communications (i.e., presentations).

• Create a data review document with data handling rules for review by the CPP Leader prior to conducting the final analysis.

• Performs analysis QC for oth...