Senior Scientist Clinical Pharmacokinetics (PK Scientist)
Job Function
Discovery & Pre-Clinical/Clinical Development
Job Sub Function
Pharmacokinetics & Pharmacometrics
Job Category
Scientific/Technology
Job Description
The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible, in collaboration with the CPP Leader, for end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1-owned studies including protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating the 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. The PK Scientist also supports all other studies in any phase of development, including noncompartmental clinical pharmacology analysis and PK/PD NCA for all study phases (Phase I‑IV).
Main Accountabilities
* Author the CP sections of the protocol, coordinate overall development, and ensure timely approval and issuance of the document.
* Participate in development and review of CP sections for protocols in therapeutic areas that require serial PK/PD sampling and non‑compartmental analysis.
* Provide QC review of protocols written by other CPP PK Scientists.
* Review non‑compartmental analysis trial‑specific data transfer agreements 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 phases, preparing final NCA output including tables, graphs, and PK/PD attachments for the Clinical Study Report, and support departmental data communications.
* Develop CP sections for CSRs under CPP ownership and facilitate timely review and approval.
* Provide tables and figures for regulatory submission documents (e.g., NDA, sNDA).
* Establish and maintain relationships with other departments (Data Management, BDDS, GCO, Regulatory, etc.) to facilitate on‑time deliverables.
* Ensure all study documentation is managed and maintained on the CPP Repository and archived according to 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.
* Work effectively in a matrix environment, managing CP deliverables according to timelines and project goals.
* Apply regulatory guidelines (FDA, EMEA, ICH, etc.) in the design of clinical development plans and studies.
* Apply relevant technical training to daily responsibilities, focusing on value/impact delivery.
Requirements
* Bachelor’s degree or higher and/or equivalent with a science background; minimum 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 Office suite.
* Demonstrated organizational and leadership skills to manage multiple priorities across projects.
* Good oral and written communication skills.
* Understanding of the overall drug development and pharmaceutical R&D process.
* Estimated 5% domestic and international travel.
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.
#J-18808-Ljbffr