Yu-Jing Gao, MD, PhD

Senior Medical Director, DSPV @ Dianthus Therapeutics, Inc.

About

An experienced Safety Physician in both global Pharma and Biotech, with deep expertise ranging from small / large molecules to biologics—including monoclonal antibodies (mAbs) and cell and gene therapies. Therapeutic area experience includes oncology, neurology, and neuromuscular rare diseases, spanning the full product lifecycle from first-in-human trials through post-marketing. Holds a MD from China, a PhD from Japan, and post-doctoral training in Canada, with over 15 years of experience in the pharmaceutical industry. Previous roles include Study Director of Toxicology and Safety Pharmacology at Merck, Assistant Professor in the Department of Anesthesia at McMaster University, and Principal Investigator funded by the Heart and Stroke Foundation of Canada (HSFC) and the Canadian Institutes of Health Research (CIHR). Recipient of multiple personal awards from a wide range of organizations. Multilingual—fluent in English, Japanese, and Chinese.

Country

United States

City

Basking Ridge

Industry

Pharmaceuticals

Skill

Experience

Senior Medical Director, DSPV

Dianthus Therapeutics, Inc.

2024-12 - Present · 1 yr 10 mos

Senior Medical Director (Drug Safety and Pharmacovigilance), responsible for overseeing the clinical developments of complement therapeutic products in multiple rare neurological disease indications

Senior Medical Director, Pharmacovigilance

Arvinas

2022-10 - 2024-9 · 2 yrs

Connecticut, United States

Senior Medical Director (Pharmacovigilance) responsible for multiple development PROTAC products in Oncology and Neurology

Sr. Medical Safety Lead, Cell & Gene Therapy, Global Drug Development

Novartis

2022-5 - 2022-10 · 6 mos

East Hanover, NJ, USA

Senior Medical Safety Lead responsible for multiple Cell & Gene programs including post-marketing and development products. A core member of multiple development teams with the following responsibilities: approval of ICSR assessments, investigator notifications, aggregate data review, periodic aggregate safety reports (PSUR, DSUR, 6-month line listing, etc.), market authorization renewal, IB and study protocol preparation and review, RMP / development safety profile plan, signal detection and evaluation, health authority requests, and CSR review. Responsibilities also include safety expert due diligence review for licensing-in products, pharmacovigilance activity with license partners, approval of literature review, and coaching junior staff including CRO, etc.

Medical Safety Lead / Pharmacovigilance leader

Novartis

2018-6 - 2022-4 · 3 yrs 11 mos

East Hanover, NJ, USA

Safety physician in Global Drug Development and Translational Clinical Oncology, Novartis, responsible for multiple programs (targeted therapy, immunotherapy, and cell/gene therapy). A core member of multiple development teams with the following responsibilities: approval of ICSR assessments, investigator notifications, aggregate data review, periodic safety reports (DSUR, PSUR), IB and study protocol preparation and review, development safety profile plan, signal detection and evaluation, health authority requests, and CSR review. Responsibilities also include safety expert due diligence review for licensing-in products, pharmacovigilance activity with license partners, approval of literature review, and coaching junior staff including CRO, etc