Senior Principal Scientist Clinical Pharmacokinetics in Antwerp, Belgium

Senior Principal Scientist Clinical Pharmacokinetics – 2406198654W

Description

Position : Senior Principal Scientist, Clinical Pharmacokinetics

Department : Clinical Pharmacology & Pharmacometrics

Division: Global Development

Objective of Position

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).

Main Accountabilities

• For clinical pharmacology trial protocols, author the protocol and coordinate the overall development of the protocol with study team members, and ensure timely approval and issuance of the document.

• Provide QC review of protocols as needed

• Review dataset requirements (i.e., trial specific data transfer agreement) for clinical studies with non-compartmental analysis (NCA).

• Write the Clinical Pharmacology Analysis Plan (CPAP) based on the protocol and internal guidelines.

• Perform preliminary, interim, and final PK, PD, and/or PK/PD analysis for trials in all phases of drug development.

• Creation of tables, listing and figures based on the CPAP.

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

• Draft the clinical pharmacology sections of the Clinical Study Report, coordinate the review, and finalize the report for signature.

• QC of analysis, all delivered outputs, and of documents reporting the analysis

• Mentor and train junior PK Scientists in protocol writing, analysis, and CP CSR section writing.

• Address data flow process and analyses questions from CP Leaders and stakeholders.

• Establish and maintain excellent/cooperative relationships with other departments (Data Management, BDDS, Regulatory, etc.) to facilitate the on-time (or expedited) deliverables and work with those departments in implementing efficiences.

• Present enhancements and process updates at departmental and cross-functional meetings

• For regulatory submission documents (e.g., NDA, sNDA, MAA, Type II variation etc.), provide PK tables and figures for study-specific summaries and if necessary, support the development of other PK/PD related sections.

• Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.

• Ensures all study documentation generated by CPP are properly managed and maintained on the CPP Repository, and are ultimately submitted for long-term storage in archival per Johnson & Johnson Record Retention Schedules.

Other Accountabilities & Tasks

• Perform literature searches and summarize the findings.

• Contribute to preparation of IB, INDs, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs.

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

• Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact.

Qualifications

Minimum Qualifications / Experience

• Bachelor’s degree or higher and / or equivalent preferably with science background. Minimum of 10 years of clinical experience.

Minimum Technical Knowledge and Skills

• Advanced knowledge of PK and statistical principles.

• Experience mentoring junior colleagues.

• Excellent data handling skills and working knowledge of database structures (e.g., SDTM, ADaM)

• Experience with Phoenix WinNonlin and R is mandatory.

• Working knowledge of Microsoft suite of software products.

• Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.

• Good oral and written communication skills in English.

• Excellent presentation skills

• Basic understanding of overall process of drug development, regulatory guidance relevant to PK analysis and reporting, and the overall pharmaceutical R&D process is preferred.

Other Requirements

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

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Other Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Basel-City-Basel, NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Ireland, NA-US-New Jersey-Titusville, NA-US-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, NA-US-New Jersey-Raritan

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Pharmacokinetics & Pharmacometrics

Req ID: 2406198654W