Senior Scientist Clinical Pharmacokinetics

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 summarise findings.
• Contribute to preparation of IB, INDs, briefing books, submission packages, and other regulatory documents to support clinical studies and programmes.
• 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