Senior Pharmacometrician 药代动力学专家

该职位来源于猎聘 Brief Position Description The Senior Pharmacometrician (SPMET) is primarily responsible for developing and executing pharmacometrics (PMx) strategies and PMx analyses in relation to preclinical and clinical studies that include but are not limited to non-compartmental analysis (NCA), population pharmacokinetics, exposure-response, pharmacodynamics (PD), disease progression modelling, model-based meta-analysis and physiologically based pharmacokinetics (PBPK). The SPMET works closely with biostatisticians and statistical programmers for specification and development of PMx technical deliverables.

The SPMET supports PMX team members in achieving their PMx technical deliverables.

Responsibilities

• Projects/Clinical/Preclinical studies
• Develop PMx strategies and contribute to the clinical development plan and identify opportunities where model-informed drug development can advance the understanding of the drug's pharmacological activity, efficacy and safety.
• Provide input to the clinical study budget and timelines with respect to the PMx work involved.
• Provide PMx input to the clinical study protocol as well as the Statistical Analysis Plan (SAP).
• Plan and execute quantitative analyses undertaken by

PMx team members which may include non-compartmental PK analysis, population pharmacokinetics, exposure response, pharmacodynamics, disease progression modeling, model-based meta-analysis as well as physiologically based pharmacokinetics (PBPK).

• Ensure the timely delivery of

PMx documents

(e.g., dataset specification, analysis plans, and reports)

and documents where

PMx is co-author

(e.g., clinical development plan, submission packages), and liaise with biostatisticians, statistical programmers, medical writers, project managers, sponsor and other stakeholders.

• Represent Novotech at client meetings (China and Global).
• Maintain documentation and program files within project files and maintain timesheets.
• Contribute to the regulatory submission packages and participate in regulatory meetings as appropriate.
• Team
• Participate in meetings of the pharmacometrics team and Drug Development Consulting (DDC) teams.
• Train and mentor junior members of the department as required.
• Peer review PMx documents and programs as required.
• Participate in audits.
• Software Tools and Program Libraries
• Ensure proficiency with the company’s

PMx software systems including WinNonlin, NONMEM, SAS and R.

• Contribute to the standardization of programs for PMx analyses.
• Pharmacometrics Processes and SOPs
• Ensure compliance with Novotech’s corporate SOPs and regulatory guidelines applicable to PMx considerations and analysis for special populations, diseases or decision-making (e.g.Bioavailability/Bioequivalence (BA/BE)).
• Adhere to SOPs and best practice instructions and templates related PMx and use of CDISC standards applicable to the PMx area.
• Propose and assist in the development and updating of

SOPs and best practices, process improvement, quality control and governance related to all technical design matters.

Minimum Qualifications & Experience 1、Masters or PhD in Clinical Pharmacology, Pharmacy, Biology, (Bio)Statistics with expertise in non-compartmental PK analysis, advanced PK-PD modelling and Pharmacometrics and a minimum of 5 years of pharmaceutical industry, CRO or related experience.

2、Proficiency with Microsoft Office tools (e.g. Word and Excel) and standard statistical and/or pharmacometrics software (WinNonlin, NONMEM, R, SAS), and familiar with regulatory validation requirements of software programs developed for PMx analyses.

3、Thorough understanding of CDISC standards in relation to PMx deliverables at study level and product level. Familiar with other China and major global regulatory guidelines regarding PMx design considerations and analysis methods applicable to special patient populations, diseases, and decision-making (e.g.

4、Bioavailability/Bioequivalence (BA/BE). Strong intra- and inter-communication skills in Chinese and English.