Senior Scientist Clinical Pharmacokinetics

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, 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.

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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, Breda, Netherlands

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium, Netherlands
- Requisition Number: R-063121

United Kingdom
- Requisition Number: R-065897

Johnson & Johnson is currently seeking a Senior Scientist Clinical Pharmacokinetics (PK Scientist) to join our team.

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

Additional responsibilities include the support of all other studies in any phase of development which include noncompartmental clinical pharmacology analysis (and all associated activities). The PK Scientist role is also responsible for PK/PD NCA for all study phases (Phase I-IV).

• 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.

• 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 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 CPP PK Scientists.

• Review non-comparatmental analysis (NCA) 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 NCA for trials in all phases of drug development. Prepares the final NCA output including in-text tables and graphs (and PK/PD attachments) 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.

• P…