Gailing Li

Senior Vice President @ Certara

About

A quantitative Clinical Pharmacologist with excellent academic credentials with a wide range of experience from early drug discovery to late phase clinical trials and new drug registration in Certara (2021-2024, China), Johnson & Johnson (2011-2021, China), Pfizer Ltd (2006-2011, UK), GlaxoSmithKline (2002-2006, UK), LACDR (1997-2002, NL) and WBL Peking Univ. Biotech (1993-1996, China). Extensive clinical development experience of small molecules and biologics in multiple therapeutic areas. A recognized expert in influencing best practices and regulatory policy in the fields of clinical pharmacology and pharmacometrics. Contributed to the development of key NMPA regulatory guidance, e.g ICH E5 & ICH E17 for simultaneous Asian-inclusive drug development, pediatrics drug development, MIDD, Drug-Drug Interactions, Clinical Pharmacology Guidance for Innovative Medicines and Implementation of ICH S7B and ICH E14 etc. Promoted & led training programs on Translation and Early Development in collaboration with Peking Univeristy and DIA since 2018 to enpower the rapid growth of innovative drug discovery & development in China/APAC region.

Country

City

China

Industry

Hospital & Health Care

Skill

Clinical Pharmacology, Pharmacokinetics, Clinical Development, Pharmacology, Drug Discovery, Pharmacodynamics, Drug Delivery, Clinical Trials, Clinical Study Design

Experience

Senior Vice President

Certara

2021-10 - 2024-7 · 2 yrs 10 mos

Beijing/ Shanghai, China

Build the Integrated Drug Development services in China. Act as Certara’s scientific lead towards Biotech/Biopharma clients, and academic & regulatory partners in China. Connect Biotech/Biopharma companies in China/APAC region with our experienced global drug developers with unparalleled insights of both FDA/EMA regulatory science and market access, plus world-leading model-informed drug development (MIDD) expertise at Certara. Partner with global clients to navigate the evolving system of drug development and regulatory landscape in China/APAC and seize opportunities for accelerated regulatory pathways and simultaneous clinical development.

Sr. Director, Head of Clinical Pharmacology (China)

Johnson & Johnson

2011-7 - 2021-10 · 10 yrs 4 mos

Beijing City, China

Head of Clinical Pharmacology in China Janssen Pharmaceutical R&D. Took a role to build up Clinical Pharmacology function in China and provide strategic and scientific contributions to the end-to-end China R&D programs. Led China BLA/NDA fillings and approvals for over 30 drugs in disease areas of oncology, infectious disease, neurology, cardiovascular/metabolic disease and immunology, supported discovery & translation research for multiple NMEs in China