Yuanbin Hao

Yuanbin Hao

Head of DMPK @ 先声药业

About

Professional Summary / Core Competencies Extensive Industry Experience: Years of experience across pharmaceutical sponsors (Client-side), CROs, and GLP laboratories. Well-versed in preclinical, Phase I, and Bioequivalence (BE) studies, with a deep understanding of NMPA and FDA regulations. GCP certified. DMPK Expertise: Specialized in small molecule pharmacokinetics with additional project experience in peptides, oligonucleotides, and PROTACs. Capable of independently leading the full DMPK workflow for innovative drugs from Discovery to IND filing. Therapeutic Areas: Proven track record in drug R&D for Oncology, Central Nervous System (CNS), Immunology (Autoimmune), and Anti-infectives. Lab Management & Operations: Expert in GLP DMPK bioanalytical laboratory operations. Skilled in establishing comprehensive SOP management systems with hands-on experience in laboratory setup (greenfield) and daily operational management. Technical Proficiency: Highly proficient in LC-MS/MS and GC-MS/MS technologies. Extensive experience in method development and validation for small molecule compounds. Leadership & Soft Skills: Strong project management and cross-functional coordination skills (upward and downward management). Excellent communicator, quick learner of emerging technologies, and a collaborative team player.

Country

China

City

Nanjing

Industry

Outsourcing/Offshoring

Skill

DMPK

Experience

Simcere Pharmaceutical Group

Head of DMPK

Simcere Pharmaceutical Group

LinkedIn
2019-7 - Present · 7 yrs 3 mos

南京

Led a team of 7. Headed the DMPK strategies for innovative drug pipelines from Discovery to IND. Focused on CNS and Immunology therapeutic areas, while also overseeing anti-infection and oncology projects. Formulated customized DMPK standards and research strategies tailored to specific project requirements. Delivered comprehensive data including in vitro ADME, Met-ID, in vivo PK, and PK/PD modeling to project teams. Collaborated closely with Medicinal Chemistry, Pharmacology, and Toxicology departments to accelerate project milestones. Partnered with Clinical Pharmacology to provide Human PK Prediction and FIH (First-in-Human) dose escalation strategies. Managed IND-enabling studies within the DMPK scope; selected and supervised CROs to ensure high-quality and timely delivery of outsourced research.

南京明捷生物医药检测有限公司

生物分析负责人

南京明捷生物医药检测有限公司

LinkedIn
2017-12 - 2019-6 · 1 yr 7 mos

南京

Method Development and Validation Responsible for the development, validation, and transfer of bioanalytical methods for small molecule drugs. Ensure that biological sample analysis and data processing strictly adhere to regulatory requirements and protocols. Team Management and Project Execution Lead the bioanalytical team in troubleshooting and resolving technical issues throughout the project lifecycle. Manage project timelines to ensure the timely completion of bioanalytical tasks while maintaining full compliance with all standards. Quality Management Optimize and upgrade the Quality Management System (QMS) in alignment with GLP/CNAS and current regulatory guidelines. Develop and oversee the execution of training programs. Provide technical guidance on experimental operations and enforce laboratory best practices (SOPs). Equipment Management and Maintenance Oversee the timely maintenance and calibration of bioanalytical instrumentation. Ensure all equipment remains in optimal working condition to prevent downtime.

南京海纳医药科技股份有限公司

生物分析中心负责人

南京海纳医药科技股份有限公司

LinkedIn
2014-12 - 2017-12 · 3 yrs 1 mo

南京

江苏鼎泰药物研究股份有限公司

DMPK Study Director

江苏鼎泰药物研究股份有限公司

LinkedIn
2010-7 - 2014-11 · 4 yrs 5 mos

南京

Education

Nanjing Agricultural University

Nanjing Agricultural University

LinkedIn

临床兽医学

2007-9 - 2010-7 · 2 yrs 11 mos

Yuanbin Hao's Contact Information

Email

******@***.com

Phone

(**) *** ****

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