Alyssa Boler
Drug Product Development | Regulatory Strategy | Program Management | Team Leader
- Role
- Associate Director, Drug Development & Regulatory Strategy at Labcorp
- Location
- Shelby County, TN, US
- LinkedIn followers
- 500 followers
About Alyssa Boler
I am a Scientist and program manager with extensive experience in pharmaceutical product development. I am a proven organizational leader with knowledge in developing pharmaceutical therapies, recognizing risks in the development pathway, and providing risk mitigation. I am proficient in communicating and working as a team through virtual platforms. I have experience in pharmaceutical development and strategic portfolio planning to gain investment, regulatory approval, and successful commercial launch. My strengths include building up internal and outsourced teams to develop and execute pipeline development strategies, analyzing risks and developing risk mitigation strategies, communicating clearly, and working with key product teams to ensure alignment of the TPP and global development strategy with the company goals.I have experience in aspects of the pharmaceutical development pathway from proof of concept, CMC, non-clinical safety, and clinical development which provides me insight into the challenges and risks of the different stages and milestones of drug development. I have a proven ability to manage large projects while becoming quickly proficient in new indications/disease states. Having both a scientific and business background has provided significant value in being able to communicate effectively with scientists in research & development and with stakeholders and potential investors.Expertise:• Project/Program Management• Pharmaceutical Product Development & Portfolio Strategy• Communication with Research & Development Scientists, Subject Matter Experts, Stakeholders, and Investors• Market Analysis• CRO/CMO Management• Financial Management of Government Contracts/Investment Funds• Analytical/Bioanalytical Methodology• Mass Spectrometry• Regulatory Strategy• Scientific Writing/Data AnalysisI am also an enthusiastic elementary and middle school track coach.
Experience
Associate Director, Drug Development & Regulatory Strategy
Apr 2023 — Present
Provide scientific leadership and direction to pharmaceutical/biotech clients regarding their drug development programs. Support clients with pre-clinical proof of concept, pre-clinical toxicology studies, development strategy, and interpretation of regulatory guidance
Education
The University of Tennessee Health Science Center
Ph.D, Molecular Therapeutics/Biomedical Research
2005 — 2010
Doane University
B.S., Chemistry, Biology
2002 — 2005
University of Nebraska-Lincoln
MBA, Finance
2008 — 2011
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