San Francisco Bay Area
Accelerate cellular therapy trial activation by providing cross-functional research compliance support and direction. Manage and develop infrastructure support for investigators and study teams seeking regulatory compliance support with local, institutional, and federal requirements. Participate in pre-IND and IND initial and renewal filings with the FDA, maintain audit readiness, and submit regulatory reports as needed.
- Supervise staff (7) providing support to clinical investigators and operations team with managing trial startup, maintenance, and data reporting for phase 1-3 industry-sponsored, investigator-initiated, and cooperative group trials. - Lead business process improvements for project managers to decrease startup timelines by collaborating closely with trial startup specialists, team managers, industry stakeholders, and principal investigators for industry sponsored and investigator-initiated trials. - Create process optimization tools, guidelines, SOPs to support ongoing regulatory tasks associated with entire lifecycle of protocols from development to completion.
Advise the editorial and content developmental teams with medical scoping and content creation for public readership. Serve as knowledge expert on specific cancers to ensure medical accuracy and appropriateness for consumer health audience.
Concurrently facilitated multiple Phase I industry-sponsored and investigator-initiated oncology trials in the early phase developmental therapeutics unit. Responsible for day-to-day clinical operations that included: - Simultaneously managing 15 or more active trial participants across 4 trials in accordance with protocol-specific procedures, reporting guidelines and unique study logistics - Maintaining up-to-date ISFs, internal tracking tools, and CTMS (OnCore). - Reporting accurate data and events to respective sponsors and investigators. - Analyzing participate response data and reporting for publications, conferences, and presentations. - Coordinated teleconference calls, SIVs, IMVs, and COVs.
Managed the Office of the Chief Scientific Officer with programs and initiatives. Implemented organizational-level policy developments, scientist performance evaluation metrics, scientific merit review processes for government grants, and develop in-house junior-scientist support mechanisms by way of post-doc program development and strategic research initiatives. Participated in grant submission cycles that included: - UM1 sample size projections using SEER registry database. - Drafted 3 grant proposals including key sections involving personnel, scientific background, and 5-year study cost projections. - Coordinated in-house IRB submissions and responses to review queries.
5-year class reunion planning committee Liaised with student body and faculty Organized and school-wide activities, events, and socials