Senior Scientist, Clinical Pharmacology

Johnson & Johnson

4.2

(92)

Shanghai, China

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2406188023W

    Position summary

    e 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.

    Qualifications

    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.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.