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Purpose: 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).

You will be responsible for:

Accountabilities with assistance from senior members of the group:

• 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. If necessary, performs review and QC of the protocol.

• 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 the 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 PK Scientists. • Review 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 PK/PD NCA for trials in all phases of drug development. Prepares final NCA output in tables and graphs 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 analysis QC for other PK Scientists.

• For CSRs under the ownership of CPP, provide the in-text PK/PD tables and figures and PK/PD attachments 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 PK/PD in-text tables and figures for the document as well as the PK/PD attachments.

• Performs CP section CSR review and QC for other 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 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.

Other Accountabilities & Tasks

· Perform literature searches and summarize the findings.

· With oversight, contribute to the 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.

Qualifications / Requirements:

· Bachelor’s degree or higher and / or equivalent preferably with science background. Minimum of 4 years of relevant work experience.

Minimum Technical Knowledge and Skills

· Working knowledge of PK, PD, and statistical principles.

· Working knowledge of Microsoft suite of software products.

· Hands-on experience with Phoenix WinNonlin and R is preferred.

· Good oral and written communication skills.

· General understanding of overall process of drug development and the overall pharmaceutical R& D process is preferred

Other Requirements

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