Xue Snow G.

Senior Vice President, Clinical Pharmacology @ BridgeBio

About

- Strategic and innovative leader with expertise in clinical pharmacology and DMPK supporting preclinical and clinical drug development across a wide range of therapeutic areas. - Extensive experience in the design and execution of fit-for-purpose model-based clinical pharmacology strategies and clinical pharmacology studies for global regulatory approvals of marketing applications. - In-depth knowledge of the overall drug development process and FDA/EMA regulations and guidelines. - Proven track record in leading projects and cross-functional teams, managing resources and budgets with strong analytical and problem-solving skills. Specialties: Clinical Pharmacology | Drug Metabolism and Pharmacokinetics | Drug Development | Project Management | Regulatory Affairs Certification (RAC)

Country

United States

City

San Francisco Bay Area

Industry

Biotechnology

Skill

Regulatory Approvals, Clinical Pharmacology, Drug Development, Clinical Development, DMPK, Leadership, Cross-functional Team Leadership, Drug Discovery, Pharmacokinetics, Pharmaceutical Industry, Drug Metabolism, Bioanalysis, Immunology, Chemistry, LC-MS, Oncology, Biotechnology, Life Sciences, Regulatory Affairs

Experience

Senior Vice President, Clinical Pharmacology

BridgeBio

2024-1 - Present · 2 yrs 9 mos

Vice President, Clinical Pharmacology

BridgeBio

2021-3 - 2023-12 · 2 yrs 10 mos

- Provide strategic leadership and be accountable for QED Clinical Pharmacology, quantitative analyses, and DMPK aspects of global oncology and non-oncology pediatric clinical development programs. - Develop and execute model-based clinical pharmacology strategies to ensure efficient achievement of clinical and drug development objectives for global marketing applications - Lead Clinical Pharmacology in the interactions with global Health Agencies including the approval of Truseltiq in the US and ex-US countries. - Oversee the design and execution of clinical pharmacology studies, Population PK, exposure-response, PK/PD modeling, ADME, and toxicology studies

Investor & Screening Committee Member

Life Science Angels

2020 - Present · 6 yrs

Exclusively invest in life science deals Bio screening committee and due diligence team member

Senior Director, Clinical Pharmacology and Quantitative Sciences

Nektar Therapeutics

2011 - 2021 · 10 yrs

San Francisco

- Led clinical pharmacology of early and late-stage drug development programs for small molecule and biological drugs in several therapeutic areas including oncology, immunology, and CNS diseases. - Developed and executed model-based clinical pharmacology strategies to ensure efficient achievement of clinical and drug development objectives for marketing applications. - Contributed to regulatory dossiers, and successful IND and NDA submissions. Experienced with interactions with regulatory agencies, label negotiation, on-site regulatory inspection, and advisory committee meeting.

Associate Director, Head of Drug Metabolism and Pharmacokinetics at Stiefel, a GSK company

GSK

2007 - 2011 · 4 yrs

- Directed and led Department of Drug Metabolism, Pharmacokinetics and Bioanalysis to support global preclinical and clinical drug development programs. - Contributed to multiple successful IND submissions and NDA approvals as clinical pharmacology and DMPK lead. - Led cross-functional project teams and managed budget. - Represented DMPK and clinical pharmacology in due diligence for Stiefel/GSK in-licensing opportunities and acquisition target program portfolio