Katherine T. Scott, Phd Email & Phone Number

Boston, MA, US

CSI is developing a portfolio of contrast agents for image-guided surgery, using low levels of near-infrared (NIR) fluorescent light for intraoperative anatomical enhancement. My role includes clinical strategy and planning, operational leadership, vendor and stakeholder management, risk management and quality assurance, performance metrics and reporting.

Indianapolis, Indiana, US

• New England Research Institutes (NERI) specialized in rare, orphan and understudied diseases in pediatric, minority, underserved and elderly populations, frequently using novel outcome assessment markers, for.
• Guided and encouraged multiple cross-functional teams in planning & executing global IDE and IND trials, registries and observational studies, from proof-of-concept to post marketing approval
• Acted as client liaison and point of escalation. Developed protocol and manuscript content. Assessed project risks proactively and recommended mitigation strategies. Ensured deliverable timelines were met and studies.
• Partnered with clinical operations teams. Reviewed and critiqued data and output from statistical analyses, refined eCRF edit checks and site queries; wrote/proofread adverse event narratives, verified MedDRA codes.
• Authored all regulatory authority, data safety (DSMB) and client reports, with statistical input
• Developed and fostered relationships with sponsors, vendors, investigators and KOLs

Durham, North Carolina, US

• Headed clinical trials utilizing imaging (CT/MRI/X-Ray/PET/bone scan (99mTc-MDP, 18F-NaF, FDG-PET)/ OCT/ fundus photography/fundus autofluorescence) from handoff to closeout in Phase I - III oncology, MSK, neuro and.
• Served as medical lead for 4 trials for which FDA approval was granted in therapeutic areas of breast cancer, ovarian cancer and renal cell carcinoma
• Reported Oncologic Drug Advisory Committee (ODAC) decisions and recommended strategy.
• Implemented medical strategy for ophthalmology trials
• Consulted with pharmaceutical trial sponsor teams for protocol design, implementation, published assessment criteria clarification and modification (RECIST 1.0 & 1.1, IWG-NHL, PCWG2, RANO, RAMRIS, vdH-modified Sharp.
• Reviewed data, resolved quality and personnel issues, presented at investigator meetings

Translated modern clinical diagnostics from human to veterinary MRI in a small start-up company. Role ended when company went into receivership.

• Managed the MR component of the $60M NIH/NIA Alzheimer's Disease Neuroimaging Initiative (ADNI) study, on behalf of the SMS USA MR R&D organization.
• Recruited to provide neuro support for functional imaging on 3T head-only systems, role evolved to encompass all neuro research applications on 3T whole body systems.
• Evaluated and managed research relationships with key 3T collaboration partners at East coast sites and all users of neuroimaging work-in-progress packages in the USA.
• Advised research, management, technical and medical staff internally and externally.
• Supported other R&D scientists, technical support and service personnel; resolved technical issues (hardware,software and applications) for research customers.
• Wrote technical articles for Siemens customer (Magnetom FLASH) magazine and presented regular updates to the R&D group.

Phd, Magnetic Resonance Imaging And Spectroscopy In Cancer Medicine

Bsc, Physics

Msc, Medical Physics