Senior Scientist Clinical Pharmacokinetics in High Wycombe

Location: High Wycombe, Buckinghamshire, United Kingdom

Job Category: Scientific/Technology

Job Sub Function: Pharmacokinetics & Pharmacometrics

Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for the end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1‑owned studies including protocol development, pharmacokinetic/pharmacodynamic data analysis, generating the in‑text tables and figures and PK/PD attachments for clinical study reports, and contributing to CTD regulatory submission documents. Additional responsibilities include supporting all other studies in any phase of development, including non‑compartmental clinical pharmacology analysis, and handling PK/PD NCA for all study phases (Phase I‑IV).

Main Accountabilities:

• For clinical trial protocols under CPP ownership, author CP sections of the protocol, coordinate overall development, and ensure timely approval and issuance.
• For clinical trial protocols under therapeutic area ownership with serial PK/PD sampling requiring NCA, participate in development and review of CP sections.
• Participate in protocol training of PK/PD‑related procedures for clinical study center personnel (SIV) if necessary.
• 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 Clinical Pharmacology Analysis Plan based on the protocol.
• Perform pre‑DBL, interim, and final NCA for trials in all phases; prepare final NCA output with in‑text tables and graphs (and PK/PD attachments) for the CSR and presentations as needed.
• Create a data review document with data handling rules for CPP Leader review before final analysis.
• Perform QC on analysis performed by other CPP PK Scientists.
• For CSRs under CPP ownership, develop CP sections and facilitate timely review and approval.
• For CSRs under therapeutic area ownership with serial PK/PD sampling requiring NCA, develop CP sections.
• Perform CP section CSR review and QC for other CPP PK Scientists.
• For regulatory submission documents (NDA, sNDA, etc.), provide tables and figures for study‑specific summaries and support other PK/PD sections as needed.
• Maintain excellent cooperative relationships with other departments (Data Management, BDDS, GCO, Regulatory, etc.) to ensure on‑time deliverables.
• Carry out functional responsibilities in accordance with applicable SOPs, regulatory requirements, and Johnson & Johnson Credo principles.
• Ensure all study documentation generated by CPP is properly managed, maintained on the CPP Repository, and archived per record retention schedules.
• Mentor junior CPP PK Scientists on medical writing and NCA.

Other Accountabilities & Tasks:

• Perform literature searches and summarize findings.
• Contribute to preparation of IB, INDs, briefing books, submission packages, and other regulatory documents to support clinical studies and programs.
• Work effectively in a matrix environment, managing CP deliverables according to timelines and project goals.
• Become familiar with and apply appropriate regulatory guidelines (FDA, EMA, ICH, etc.) in the design of clinical development plans and studies.
• Apply technical trainings and learnings to daily responsibilities, focusing on value and impact delivery.

Requirements:

• Bachelor’s degree or higher and/or equivalent 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 required; R preferred.
• Working knowledge of Microsoft Office suite.
• Demonstrated organizational and leadership skills to handle multiple competing priorities across projects.
• Good oral and written communication skills.
• General understanding of overall drug development and pharmaceutical R&D processes preferred.
• Estimated domestic and international travel of about 5% of time.

Required 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

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