Senior Scientist Clinical Pharmacokinetics
Johnson & Johnson
- Beerse, Antwerpen
- Vast
- Voltijds
- 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 Phase 1 Clinical Pharmacology trials, and facilitate a timely review and approval of those sections.
- Perform CP section CSR review and QC for other PK Scientists.
- For regulatory submission documents (e.g., NDA, sNDA, MAA, Type II variation etc.), provide tables and figures for study-specific summaries and if necessary, support the development of other PK/PD related sections.
- Establish and maintain excellent/cooperative relationships with other departments (Data Management, BDDS, Regulatory, etc.) to facilitate the on-time (or expedited) deliverables.
- 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.
- 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.
Bachelor's degree or higher and / or equivalent preferably with science background. Minimum of 6+ years of clinical experience * Knowledge of PK, PD, and statistical principles.
- Excellent data handling skills and working knowledge of database structures (e.g., SDTM, ADaM)
- Experience with Phoenix WinNonlin and R is preferred.
- 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.
- General understanding of overall process of drug development and the overall pharmaceutical R&D process is preferred.