SENIOR SCIENTIST CLINICAL PHARMACOKINETICS

The Senior Scientist, Clinical Pharmacokinetics 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).
Your 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 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.
., 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.
Qualifications Education and Experience Requirements    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.
., 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.
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