Jane Meng

In charge of non-clinical development strategy from safety perspective for life cycle development, including candidate selection, IND-enabling to multiple regions for regulatory submission, and continued nonclinical development to enable late stage development, NDA application and expansion on top of current leading indications; Facilitate and execute non-clinical studies for target evaluation and other assessment on needed basis; Explore translational toxicity evaluation to facilitate early drug screening; Literature retrieval on competitor landscape and novel technologies in the field. Oversee daily departmental operations and career development for talents.

Responsible for strategic planning, execution and reporting of non-clinical pharmacology and toxicology studies and overseeing the strategic planning in allied disciplines. Partner closely with other functions to enable seamless transition of product candidates from discovery research to clinical development, and continuous development along with clinical trials, an environment characterized by rapid, integrated decision making. Deeply involved in preclinical translational medicine research, focusing on multi-platform model development for immuno-oncology drug efficacy testing and combination partner selection. Responsible for bioanalytical method validation supporting preclinical and clinical PK/ADA/Nab analysis for mono- and bispecific antibodies, as well as modified modailities with novel technology. Oversee daily administrative affaires of Beijing Center as the Site Head, and strategic development plan and execution.

Primary responsibilities include planning, coordinating, monitoring, and management programs/projects in non-clinical safety evaluation; ensure all studies are planned, executed, and completed in accordance with corporate objectives, applicable regulations, guidelines and standard operating procedures; and ensure all studies are deliverable on time with a high quality. The staff is also required to be involved in the activity of internal product development and project management and to work both independently and in a multidisciplinary team setting to ensure timely completion of programs.

• Provide clients with a consultancy and advisory service for the drug development process and work with in house scientists to plan and execute preclinical development programs. Establish client content and format requirements for documents and ensures compliance. • Meets with clients to review on-going programs and establishes future directions. • Coordinate meetings and visits with the client to ensure key individuals meet appropriate Covance personnel. Ensure that specified clients are kept up to date with new developments, capabilities and opportunities within Covance. • Establish and update individual drug development Summary Reports. • Chair project update meetings; monitors progress to establish deadlines. • Conduct pre-visit project review sessions with project teams and prepares presentation materials. Provide internal and external presentations on project/program management. • Maintain scheduling information for all departments to ensure internal resource availability for awarded studies. Monitors all ongoing projects against development timetables for their customer(s). • Provide the Commercial Organization with scientific and development field sales support. • Monitors financial aspects of programs. • Prepares project updates for the business unit managers.

 ~ 8 years Study Director for > 100 preclinical PK & toxicology studies, from PK/PD, acute to chronic studies (up to 6 months in rodents and NHPs) using various administration routes in compliance with U.S. FDA GLP, OECD Principles on GLP, and CFDA GLP to support IND and NDA (Phases I – III clinical trials), for single- or multiple-filing purpose in USA, China, and EU.  As the program manager, deeply involved in the communication with potential clients and serving as the central coordinator, closely working with BDs and internal teams, providing study designs & quotation, and overseeing program progress and problem resolving.  Skilled in study designing, planning and conducting, data interpretation, multi-tasking and trouble-shooting. Known as a group player capable of working with diverse employee populations in a global environment.  Skilled in communication with clients/sponsors regarding study design, scheduling and prompt update on study affairs. The top choice for challenging sponsors.  Experienced on handling inspections including regulatory agencies from US FDA, OECD, and CFDA, and sponsor/client audit on studies and facilities.  Oversee the daily operation of the bioanalysis group, providing regulated bioanalysis in support of GLP pre-clinical studies under principles of regulatory guidelines, as well as clinical sample analysis under GCP.  ~ 8 years in animal welfare and use committee, overseeing the animal care and use, and successfully leading to full accreditation by AAALAC 3 times.