Neil R. Michaud
Head Translational Medicine, Marengo Therapeutics | Senior oncology translational leader | Precision Medicine | Innovating trial design with Biomarker and CDx approaches
- Role
- Senior Director and Head Translational Medicine at Marengo Therapeutics
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Neil R. Michaud
Creative senior leader in oncology drug discovery and development with demonstrated leadership in the development and execution of corporate and translational departmental goals Extensive leadership responsibilities with a track record of applying innovative solutions to foster successful program milestone delivery of numerous small molecule and biologics programs through discovery into clinical development and through development from Phase 1 to Phase 3 clinical trials to FDA approval Translational medicine and biomarker expertise, including design & delivery of Precision Medicine strategies and biomarkers for agents in solid and hematological tumor indications, including successful development and implementation of companion diagnostic, patient selection and stratification, and response biomarkers; preclinical and clinical translational data generation and analysis- demonstrated leadership of translational studies and regulatory/FDA interactions with substantial experience interacting directly with FDA CDER and CDRH leading to 2020 TAVERIK and CDx FDA approval in FL Expertise in writing clinical protocols and regulatory documents (IND, IB, CSR, EOP1, EOP2, pre-NDA, NDA submissions) Extensive experience working with safety/toxicology and DMPK/clinical PK colleagues in preclinical IND-enabling and clinical trial study settings Experimental biologist by training with in-depth experience supervising molecular biology, biochemistry and cell biology functions; in vivo pharmacology expertise Accomplished people manager with direct supervisory experience of non-PhD and PhD reports and supervisory responsibilities for matrixed departmental and project team reports
Experience
Senior Director and Head Translational Medicine
Jun 2023 — Present · Cambridge, MA, US
Education
University of Rochester
M.S., Biology
University of Rochester
Ph.D., Program in Molecular, Cellular and Developmental Biology
Hobart and William Smith Colleges
Bachelor of Science (BS), Biology
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