北京招聘

1.    Support clinical pharmacology function from pre-IND to post approval for both small and large molecules (previous experience in large molecules is a plus).

2.    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-man to Phase 4).

3.    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.

4.    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).

5.    Represent clinical pharmacology in regulatory interactions (eg, pre-IND, EOP2, pre-NDA/BLA).

6.    Present clinical pharmacology results to internal and external stakeholders.

7.    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.

8.    Provide oversight and work closely with collaborators and CROs in study protocol/report review for clinical studies.

职位要求：

1.    PhD or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or other related disciplines.

2.    > 3 years of industry or equivalent experience in DMPK, PKPD, clinical pharmacology (modeling and simulation experience is a plus).

3.    Demonstrated ability to work in a highly collaborative, multi-disciplinary and dynamic team setting.

4.    Excellent verbal and written communication skills. 

5.    Proficiency in English is a plus.

6.    Self-directed and highly-motivated researcher, with willingness to learn new tools and approaches.

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。