Provided executive-level leadership to define Company’s clinical development strategy and execution, including oversight of regulatory submissions, for a first-of-its-kind device/drug combination product to address unmet clinical needs in breast cancer surgeryKey accomplishments include:--Designed and successfully executed clinical studies from Phase 1/2/Feasibility to a Phase 3/Pivotal study including a multi-center, 2-arm randomized study to prove the safety and effectiveness of the Company’s flagship combination product to support PMA and NDA submissions--Completed an NDA submission for the drug component and currently finalizing a PMA submission for the device component--Oversaw and wrote regulatory submissions including IDE/PMA and IND/NDA as the primary contact with FDA, including negotiations with CDRH/CDER for Pivotal study design and endpoints--Headed all aspects of clinical affairs including protocol creation, statistical analysis plans, data analysis and interpretation and preparation of final clinical study reports--Established strong collaboration with KOLs in surgical oncology across the US to define protocols and clinically significant endpoints for all the Company’s clinical research--Prepared and led technical presentations of device/drug mode of action and clinical results to existing and potential new investors to support fund raising efforts--Provided guidance to Product Development team for the design validation and verification campaign of the device--Head of Publications Committee, leading to 11 peer-reviewed publications and multiple conference presentations

Held multiple positions at Lumicell, a start up company that was spun off from MIT based on my post-doctoral work.As employee #2, contributed across many aspects of drug and device development and clinical research Built the clinical affairs and biostatistics/data science teams to support Lumicell’s clinical strategy--Designed and led the execution of the clinical development strategy for multi-stage feasibility studies, starting with a single site and expanding to 16 sites across USA--Initiated multiple collaborations to expand clinical studies in multiple cancer indications--Identified and selected CROs to assist in the conduct of clinical studies--Led the device development group, including overseeing and writing all IDE communications and was --established as the primary contact with FDA--Conducted negotiations with FDA to define pre-clinical safety evaluations for device and imaging agent--Conducted feasibility studies in companion dogs treated for cancer that provided relevant performance and usability data that informed the design of clinical studies in humans--Led grant-writing efforts that secured ~$10M of non-dilutive funding from multiple grants (R21, R01, SBIRs) from NCI and NSF to support development of novel technologies for intraoperative cancer detection--Co-invented, designed and developed a novel fluorescence imaging agent and a tumor detection algorithm to provide intraoperative, real-time guidance for surgeons to remove residual cancer

Developed a novel optical instrumentation for image guided tumor removal surgery and conducted proof of concept studies in mice and a clinical trial in companion dogs. The technology led to an MIT spin-off, Lumicell, Inc.

-Engineered new sensor that increased customer base and generated multi-million revenue stream-Developed test protocols and automated test set-up to conform to customer requirements and expectations-Led team of research engineers in analyzing and solving problems with existing sensors resulting in a decrease of 5% in customer warranty claims-Teamed closely with manufacturing group and second-tier suppliers to ensure proper product assembly, implementation and performance

-Led team of two engineers and five technicians in re-designing a next-generation test missile with improved performance and adaptability and reduced production costs by 15%-Developed new procedures for submarine crew training to support implementation of new test missile-Managed a testing laboratory to provide support to the US Naval submarine fleet