Dalei Shao
San Diego,CA
Summary
- Accomplished drug R&D professional with extensive expertise across all phases, from discovery to early clinical trials. Demonstrates strong strategic project planning and implementation skills, complemented by a commitment to regulatory compliance, and cross-functional collaboration. Known for analytical thinking and data interpretation abilities that drive successful outcomes. Seeking to leverage experience in a dynamic environment that fosters innovation and scientific advancement.
- Expertise in coordinating IND document writing and submissions, ensuring strict adherence to regulatory standards. Proven track record in optimizing processes to boost efficiency and accuracy across operations. Core competencies include regulatory compliance, process improvement, and project management. Committed to advancing organizational goals through meticulous attention to detail, and strategic planning.
Overview
29
29
years of professional experience
1
1
Certification
Work History
Director, Project Management
Radionetics Oncology
San Diego, USA
12.2021 - 02.2025
- Working with internal and external teams in Biology, DMPK, toxicology, CMC, Clinical Operation, and Regulatory Affairs, to identify needs and gaps to bring pre-clinical candidate to IND application and implement corresponding efforts
- Planning, budgeting and resourcing for pre-clinical candidate development
- Managing and monitoring outsourcing contracts
- Organizing cross-functional team meeting and facilitating alignment
- Coordinating IND writing and submission activities
Consultant
Self-employed
10.2020 - 12.2021
- Discovery and lead candidate selection strategy and implementation (served as an in vitro Biology head for one of the clients)
- Pre-clinical development of small molecule and biologics drug candidates (served as a PM for a biologics development project)
- CRO business development (served as a VP of BD for one of the clients)
VP/Executive Director, Business Development
Pharmaron
San Diego, USA
08.2014 - 10.2020
- Achieved 10-fold growth in annual sales in 6 years, yielding > 100million total in revenue and a strong client base
- Attracted over a dozen interdisciplinary IND enabling programs (including MedChem, Biology and DMPK screening, in vivo model development, efficacy, PK/PD studies, toxicology and safety pharmacology, process and formulation development, nonGMP and GMP manufacturing of drug substance and drug products, etc)
- Established collaborations with several NIH and NCI programs, including the NCI Chemical Biology Consortium
- Established and expanded the BD team for Southern California
Executive Director, in vitro Biology
Pharmaron
Beijing, China
04.2011 - 07.2014
- Led a biology team of up to 20 with focus on oncology assays, biomarker /PD studies, and cancer genomics to support clients (mostly US based) drug R&D needs
Senior Director, in vitro Biology
Sundia MediTech
Shanghai, China
06.2009 - 03.2011
- Built and supervised one molecular diagnosis lab, one GMP microbiology lab, and a molecular & biochemistry group
- Expanded the team from 4 to 15 people
- Supported clients from complex exploratory target validation programs to SAR campaigns
Senior Research Scientist
Merck Research Laboratories
West point, USA
11.2004 - 06.2006
- Initiated and championed a new project within three months of joining
- The project earned high priority status and later progressed to clinical trial phases
Senior Research Scientist
Wyeth WHRI
Collegeville, USA
08.1999 - 11.2004
- 2003-2004: Biology team leader of a late-stage discovery project, delivered one preclinical-candidate
- 2000-2002: Project leader of an early exploratory project, with novel mechanism and approach
Postdoctoral Research Fellow
University of Pennsylvania
Philadelphia, USA
04.1996 - 07.1999
- Company Overview: Department of Medicine, Division of Endocrinology, Metabolism and Diabetes
- Advisor: Mitchell A Lazar, M.D., Ph.D
- Published first authorship papers in high impact journals such as Nature and JCI
- Department of Medicine, Division of Endocrinology, Metabolism and Diabetes
- Advisor: Mitchell A Lazar, M.D., Ph.D
Education
PhD - Molecular and Cell Biology Program
Hahnemann University
Philadelphia, PA03.1996
BS - Biochemistry
Hanghzou University
Hangzhou, China07.1991
Skills
- Strategic planning and implementation of preclinical development projects
- Program and project management
- Cross-functional team leadership and coordination
- Change management and problem-solving
- Partnerships and alliances
- Budget and contract management
Certification
- Essentials in Project Management, Villanova University, 2003
- Mastering Project Management, Villanova University, 2003
Publications
- Identification of Novel Estrogen Receptor alpha Antagonists, Shao D
- Thomas J. Berrodin, Eric Manas, Diane Hauze, Robert Powers, Ashok Bapat, Daniel Gonder, Richard C Winneker, Donald E. Frail, J. Steroid Biochemistry & Molecular Biology, 04/2004
- Modulating nuclear receptor function: may the phos be with you, Shao D, Lazar MA, J Clin Invest, 06/1999
- Interdomain communication regulating ligand binding by PPAR-gamma, Shao D, Rangwala SM, Bailey ST, Krakow SL, Reginato MJ, Lazar MA, Nature, 11/1998
- A cysteine residue in helix II of the bHLH domain is essential for homodimerization of the yeast transcription factor Pho4p, Shao D, Creasy CL, Bergman LW, Nucleic Acids Res, 02/1998
- Peroxisome proliferator activated receptor gamma, CCAAT/enhancer-binding protein alpha, and cell cycle status regulate the commitment to adipocyte differentiation, Shao D, Lazar MA, J Biol Chem, 08/1997
- Retinoic acid blocks adipogenesis by inhibiting C/EBP-mediated transcription, Schwarz EJ, Reginato MJ, Shao D, Krakow SL, Lazar MA, Mol Cell Biol, 03/1997
- Transcriptional activation by peroxisome proliferator-activated receptor gamma is inhibited by phosphorylation at a consensus mitogen-activated protein kinase site, Adams M, Reginato MJ, Shao D, Lazar MA, Chatterjee VK, J Biol Chem, 02/1997
- Interaction of Saccharomyces cerevisiae Pho2 with Pho4 increases the accessibility of the activation domain of Pho4, Shao D, Creasy CL, Bergman LW, Mol Gen Genet, 06/1996
- Negative transcriptional regulation of PH081 expression in Saccharomyces cerevisiae, Creasy CL, Shao D, Bergman LW, Gene, 02/1996
Awards & Honors
- National Research Service Award, NIH, 07/1998-06/1999
- Member (former), the New York Academy of Science
- Member (former), the Endocrine Society
- Honored member, Strathmore’s Who’s Who, 2001-2003 editions
- Honored member, Marquis Who’s Who in America, 57th edition
Patents
- Composition, methods and kits relating to the TIG-1 gene, a novel TZD inducible gene., Mitch Lazar, Dalei Shao, W00064919 A1
- A novel voltage-gated potassium channel, rKCNQ5, for identification and development of activators and inhibitors to treat a variety of central and peripheral disorders., Tom Argentieri, Dalei Shao, Yuchen Bai, Qiang Wang, 20090276486
References
References available upon request.
Timeline
Director, Project Management
Radionetics Oncology
12.2021 - 02.2025
Consultant
Self-employed
10.2020 - 12.2021
VP/Executive Director, Business Development
Pharmaron
08.2014 - 10.2020
Executive Director, in vitro Biology
Pharmaron
04.2011 - 07.2014
Senior Director, in vitro Biology
Sundia MediTech
06.2009 - 03.2011
Senior Research Scientist
Merck Research Laboratories
11.2004 - 06.2006
Senior Research Scientist
Wyeth WHRI
08.1999 - 11.2004
Postdoctoral Research Fellow
University of Pennsylvania
04.1996 - 07.1999
PhD - Molecular and Cell Biology Program
Hahnemann University
BS - Biochemistry
Hanghzou University
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