Job Description
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 end‑to‑end Phase1 study execution of Clinical Pharmacology Phase1‑owned studies, including protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating 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.
Responsibilities
* For clinical trial protocols under the ownership of CPP, author the CP sections of the protocol, coordinate overall development, and ensure timely approval and issuance of the document.
* For clinical trial protocols under the therapeutic area ownership where serial PK/PD sampling and non‑compartmental analysis (NCA) is required, participate in development and review of CP sections.
* Participate in protocol training of PK/PD‑related procedures for clinical study center personnel (e.g., SIV).
* Provide QC review of protocols written by other CPP PK Scientists.
* Review NCA trial‑specific data transfer agreements (tsDTA) provided by the PK Office Vendor for creation of PK/PD analysis datasets.
* Create the Clinical Pharmacology Analysis Plan based on the protocol.
* Perform pre‑DBL, interim, and final NCA for trials in all development phases.
* Prepare final NCA output, including in‑text tables and graphs and PK/PD attachments for the Clinical Study Report (CSR).
* Create a data review document with data handling rules for review by the CPP Leader prior to final analysis.
* Perform QC for analysis conducted by other CPP PK Scientists.
* For CSRs under CPP ownership, develop the CPP sections and facilitate timely review and approval.
* For CSRs under therapeutic area ownership where serial PK and/or PD sampling and NCA is required, develop the CP sections.
* Perform CP section CSR review and QC for other CPP PK Scientists.
* For regulatory submission documents (e.g., NDA, sNDA), provide tables and figures for study‑specific summaries and support the development of other PK/PD related sections.
* Establish and maintain cooperative relationships with Data Management, BDDS, GCO, Regulatory, and other departments to facilitate on‑time deliverables.
* Carry out functional responsibilities in accordance with SOPs, regulatory requirements, and Johnson & Johnson Credo principles.
* Ensure all CPP‑generated study documentation is properly managed and maintained on the repository and archived per retention schedules.
* Mentor junior CPP PK Scientists on medical writing and NCA.
* Perform literature searches and summarize findings.
* Contribute to preparation of IB, INDs, briefing books, submission packages, and other regulatory documents as applicable to support clinical studies and/or programs.
* Work effectively in a matrix environment, managing CP deliverables to meet timelines and overall project goals.
* Apply relevant regulatory guidelines (FDA, EMEA, ICH) in research design and development plans.
* Apply technical trainings and learnings to daily responsibilities, focusing on value delivery.
Requirements
* Bachelor’s degree or higher, preferably with a 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; R is preferred.
* Working knowledge of Microsoft suite of software products.
* Demonstrated organizational and leadership skills to handle multiple competing priorities across projects.
* Good oral and written communication skills.
* General understanding of the overall drug development process and pharmaceutical R&D.
* Approximate travel of 5% of time, domestically and internationally.
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
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