Senior Scientist Clinical Pharmacokinetics Full-time

Senior Scientist Clinical Pharmacokinetics (PK Scientist)

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).

Main Accountabilities

• 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.
• Performs QC for analysis performed other CPP PK Scientists.
• For CSRs under the ownership of CPP, develop the CPP sections, and facilitate a timely review and approval of those sections.
• For CSRs under the ownership of the therapeutic area (i.e., Translational Medicine, Experimental Medicine, etc.) where there is serial PK and/or PD sampling and where NCA is required, develop the CP sections of the document.
• Performs CP section CSR review and QC for other CPP PK Scientists.
• For regulatory submission documents (e.g., NDA, sNDA, 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, GCO, 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.
• Mentor junior CPP PK Scientists on medical writing and NCA.

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.
• Become familiar and apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies.
• Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact.

Requirements:

• Bachelor's degree or higher and / or equivalent preferably with science background. Minimum of 4 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 is a must 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.
• General understanding of overall process of drug development and the overall pharmaceutical R&D process is preferred.
• Estimated both domestic and international travel of about 5% of time.

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Critical Thinking, Drug Discovery Development, Empowering People, Pharmacokinetic Modeling, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Scientific Research, Technologically Savvy