86 Support clinical pharmacology function from pre-IND to post approval for both small and large molecules (previous experience in large molecules is a plus).
86 Act as clinical pharmacology subject matter expert on multidisciplinary teams working closely with clinicians, biostatisticians, clinical operations, regulatory, pharmacology, toxicology, and bioanalytical colleagues to design, conduct and report clinical studies (from first-in-*** to Phase 4).
86 Responsible for study design and data interpretation of clinical pharmacology studies, including pharmacokinetics, pharmacodynamics, food effect, relative bioavailability, drug-drug interaction, QTc, ethnic PK bridging and special population studies, et al.
86 Closely working with collaborators and CROs to conduct non-compartmental and population PK, PK/PD, and exposure-response analysis to support key program decision-making (eg, phase 2/3 dose selection).
86 Represent clinical pharmacology in regulatory interactions (eg, pre-IND, EOP2, pre-NDA/BLA).
86 Present clinical pharmacology results to internal and external stakeholders.
86 Author clinical and regulatory documents related to clinical pharmacology components, including protocols, investigator brochures, study reports, briefing documents for regulatory meetings, and NDA/BLA, et al.; author scientific publications.
86 Provide oversight and work closely with collaborators and CROs in study protocol/report review for clinical studies.


职位要求：
a) PhD or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or other related disciplines.
b) >3 years of industry or equivalent experience in DMPK, PKPD, or clinical pharmacology
c) > 1 year of experience in clinical pharmacology and experience in use of WinNonlin, NONMEM, or R for population PK or PK/PD analysis.
d) Demonstrated ability to work in a highly collaborative, multi-disciplinary and dynamic team setting.
e) Excellent verbal and written communication skills.
f) Proficiency in English is a must.
g) Self-directed and highly-motivated researcher, with willingness to learn new tools and approaches.