• 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

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