北京招聘

·         Involvement and input from project entry through FIH study design, Interact with biologic and discovery research teams to address key development questions, design experiments, analyze results and provide strategic direction to help identify those constructs that have the greatest chance of success for further development or to stop the development programs.

·         Development of mechanism-based modeling and simulation to guide rational human dose projection and dose selection; Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers; Support for the efficient application and integration of PK/PD studies in support of clinical, candidate selection and lead optimization programs

·         Define PK, PK/PD, biopharmaceutical requirements in clinical project development; plan appropriate strategies in accordance with the Health Authorities requirement; contribute to the design for clinical projects; identify potential project hurdles and suggest solutions

·         Contribute expert input into regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND  and NDA's within agreed timelines; Prepare, compile, and review appropriate sections of CTA dossiers/ NDA documents; represent PK/PD in interactions with health authorities and external partners

·         Proactively manage links with other functions to ensure that pre-clinical and clinical PK/PD information are used optimally; facilitate constructive collaboration within drug development teams and with other internal partners.

·         Monitor timelines and objectives, ensure accuracy of project and activity progress, assure rapid and effective communication of high-quality data and results to project teams.

·         Conduct advanced pharmacokinetic analysis, apply PK/PD modeling concepts, and assess basic research on PK, target engagement, receptor occupancy and antidrug antibody for biologic drug candidates.

·         Accountable for determining the starting dose for FIH, write and/or review technical reports, interact with global regulatory agencies and be involved in drafting preclinical PK and related sections in an IND or CTA.

·         Monitor timelines and objectives, ensure accuracy of project and activity progress, assure rapid and effective communication of high-quality data and results to project teams

任职要求：

·         Ability to design and implement preclinical pharmacokinetic and PKPD studies required to support first in human clinical trials

·         Expertise in the application of Phoenix WinNonlin is required, and/or experience with other sophisticated modeling programs.

·         Experience with pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp) is strongly preferred.

·         Demonstrated ability to work in a matrix environment and experience working in a global environment is a plus, with experience on biotherapeutic projects.

·         Knowledge of related disciplines (e.g., biostatistics, toxicology, regulatory) in the drug development process.

·         Strong oral and written communication skills.

·         Strong organizational and project skills.

·         Critical thinking and problem solving skills.

·         Knowledge of I/O and immunology advantageous 

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.