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Director of regulatory affairs with 15 years of experience in oncology drug development looking to join a team that is passionate about advancing new treatment options for cancer patients.
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Cello Health – Midland Park, NJ,
- Oversee regulatory affairs activity for a small biotech company, including preparing IND submissions, liaison with FDA by leading formal meetings and phone/email communications, and life cycle management for several oncology products
Key Accomplishments:
- Successfully moved a novel biologic from discovery to an ongoing phase 1/2 clinical trial including managing the IND-enabling toxicology study, pre-IND meeting with FDA CBER, and full IND submission which was approved following the initial submission
- Productive and collaborative EOP2 meetings with FDA CDER for an orphan drug combination drug/device (drug primary MOA) which is now in Phase III clinical trials
American College Of Surgeons – Chicago, IL,
- Prepare pre-clinical grant applications and project management support for early R & D efforts
- Develop protocols, consent forms and regulatory documents for a new oncology product
Key Accomplishment:
- Led a successful pre-IND meeting with FDA CBER division
Children's National Medical Center – Fulton, MD,
- Project management for translational research program
- Compiled data and progress reports for preclinical research studies
Moores Cancer Center At UC San Diego Health – City, STATE,
- Built and managed queries, exports, and analysis reports for cancer center investigators and administration
- Partnered with cross-functional teams on data organization, storage, access and mapping to ensure NCI requirements were met.
- Created and facilitated in-house training program for database users.
Moores Cancer Center At UC San Diego Health – City, STATE,
- Managed upkeep of regulatory electronic and hard copy filing systems and archives.
- Developed standardized templates and training materials for IRB submissions.
- Enforced regulatory affairs department compliance with agency requirements.
- Updated in-depth trackers of approvals and submissions.
- Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
- Hired team members and trained in collaborative team environment.
Moores Cancer Center At UC San Diego Health – City, STATE,
- Prepared IRB applications, consent forms, and essential documents for over 50-60 cancer trials
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Demonstrated leadership by making improvements to work processes and helping to train others.
Moores Cancer Center At UC San Diego Health – City, STATE,
- Coordinated research activities for 160 participants in the (NCI) funded National Lung Screening Trial
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
SAN DIEGO STATE UNIVERSITY - San Diego, CA
POINT LOMA NAZARENE UNIVERSITY - San Diego, CA
Received full tuition honors scholarship, 2002-2006
VISTA GRANDE ELEMENTARY SCHOOL – San Diego, CA 09/19 – Present
Voting Member, Site Governance Team
VISTA GRANDE FOUNDATION – San Diego, CA 09/19 – Present
Voting Member
UPLIFT SAN DIEGO – San Diego, CA 09/09 – 06/12
Volunteer Tutor
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School Attended
- SAN DIEGO STATE UNIVERSITY
- POINT LOMA NAZARENE UNIVERSITY
Job Titles Held:
- Director of Regulatory Affairs
- Independent Consultant
- Data Manager
- Senior Clinical Research Data Manager
- Clinical Trials Regulatory Specialist
- Clinical Trials Regulatory Coordinator
- Clinical Research Coordinator Intern
Degrees
- Master of Public Health
- Bachelor of Arts
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