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Discovery & Pre-Clinical/Clinical Development

Senior Scientist, Clinical Pharmacology

  • 標題 Senior Scientist, Clinical Pharmacology
  • 功能 Discovery & Pre-Clinical/Clinical Development
  • 子功能 Pharmacokinetics & Pharmacometrics
  • 類別 Senior Scientist, Pharmacokinetics & Pharmacometrics (ST6)
  • 位置 Shanghai, China
  • 刊登日期
  • 參考 2406188023W
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描述

Objective of Position

The Therapeutic Area (TA) Clinical Pharmacology (CP) Senior Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply clinical pharmacology knowledge, including design of clinical pharmacology studies or clinical pharmacology component of clinical studies, pharmacokinetics/ pharmacodynamics analyses and reporting, and application of principles of model-informed drug development (MIDD) to specific studies within a program, with guidance from senior CPP leaders. With oversight, the Senior Scientist may also function as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences and Clinical Pharmacology (e.g., Statistics, Pharmacometrics) and execute the day-to-day operations pertaining to all aspects of clinical pharmacology for the programs they are assigned to.  Programs can be across all stages of drug development ranging from New Molecular Entity (NME) declaration through Post-Marketing support.  

Main Accountabilities

Accountabilities with assistance from senior members of the group:

•    Contribute to overall compound development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support dose and dosage regimen selection, and optimize study designs throughout drug development. 

•    Perform non-compartmental, population and/or modeling and simulation analysis of PK and/or PD data including preclinical-clinical translation, dose/exposure-response relationships to guide dose regimen and optimize study design. 

•    Summarize and provide interpretation of results of PK and PK/PD analyses. 

•    Contribute to the design and execution of scientifically robust and efficient clinical pharmacology strategies for development candidates. 

•    Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.

Other Accountabilities & Tasks

•    Conduct PK and PK/PD analyses, provide independent QC, and report results in appropriate format (e.g., team presentations, memo, CSR).
•    Provide protocol elements contributing to the design of Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies.
•    Manage operational elements of CPP studies with oversight from project CPP Leader.
•    Perform literature searches and summarize the findings.
•    With oversight, contribute to preparation of IB, INDs, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs.
•    Accumulate knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by taking in-house training and/or engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.).
•    Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
•    Become familiar and apply appropriate regulatory (e.g., NMPA, FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies.
•    Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact. 

資格

Minimum Qualifications / Experience

•    PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 1-3 years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 2-6 years of relevant experience. 

Minimum Technical Knowledge and Skills
•    Understanding of PK, PD, PK/PD, and/or Translational Medicine.
•    Experience with advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools a plus (e.g., Winnonlin, NONMEM, R, Gastroplus, Simcyp, Matlab)
•    Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively.
•    General understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.

Other Requirements

Estimated both domestic and international travel of about 5% of time.

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