Engagement and client advisor working with complex, cross-functional teams to bring offerings, operations, and programs to fruition.
Executive client-facing roles with large, global biopharma and healthcare companies. Past p ...see more
Engagement and client advisor working with complex, cross-functional teams to bring offerings, operations, and programs to fruition.
Executive client-facing roles with large, global biopharma and healthcare companies. Past projects include human performance, compassionate care, early-stage drug development, drug manufacturing quality control, and strategic growth playbook design.
● Competencies:
○ Strategy and Operations
○ Program and Project management
○ Change Management
○ GxP Evalgalist
○ Agile development, delivery, and production
● Selected Casework
○ Goton, CT - SME in GCP, GVP for the Franchise and be responsible for contributing (or leading as assigned) to quality initiatives. Serve as the Clinical Quality point of contact for inspections and clinical study / program compliance concerns/ escalation. Provide guidance to Clinical Business Partners to ensure compliance with purchasing controls
○ Phoenix, AZ - Business Development strategy work for growing Behavioral Health company
○ Norwood, MA - Vaccine agile manufacturing and quality control
○ Natick, MA - Human performance requirements for future long-duration human spaceflight and Phase I studies for ionizing radiation prophylactic treatment. Partners: NASA Johnson Space Center Texas, ESA Paris, Cleveland Clinic Ohio
○ Conshohocken, PA - Collaborative BioPharma. Regulatory analysis and harmonization of patient recruitment activities and efforts
○ Marlborough, MA - Medical device manufacturer. Artificial Intelligence assisted design of medical therapies for cardiovascular stents
○ Boston, MA - Expanded Access healthcare data management diagnostics business analytics. Business development and operations for Netherlands-based company expanding into the US market.
○ Medfield, MA - Clinical Trial patient identification and recruitment business analytics. Business development and operations for a German-based company expanding into the US market
○ Cambridge, MA - Senior Advisor for an End-to-end Enterprise Resource Planning (ERP) migration of servers and software as the biotech Celgene (now BMS) upgraded capability of clinical trials data sources, EDC, Master File, CTM systems, data quality processes, and data architecture for their rapidly expanding pipeline. Total effort: 1 year
● Pro-bono assistance
○ EndCoronaVirus.org - Functional Genomic and Bioinformatic Advisor, Literature Reviewer
○ Annotator of Hypothes.is, an online collective of professionals ensuring information flow is accurate
○ Mt. Nittany Medical and Hershey Medical Center, PA - Molecular and Functional Genomic Advisor for COVID-19 response and testing evaluation
