Senior Scientist Clinical Pharmacokinetics

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 Phase 1 study execution of Clinical Pharmacology Phase 1‑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