Clinical Consultant - Independent
(2024-05)
- Advise pharmaceutical, Biotech, and CROs on a broad spectrum of clinical, safety, and regulatory affairs issues.
- Serve as a medical monitor, safety physician, or sponsor representative for Phase I to III studies.
Principal Clinical Consultant - DataRevive / Validant / Eliquent - Rockville, MD
(2019-05 - 2024-05)
Regulatory Consulting Firm
- Advise pharmaceutical sponsors on clinical development from first-in-man through marketing application across a variety of therapeutic indications.
- Extensive experience with FDA interactions, including end-of-phase 1, 2, and pre-marketing applications.
- Advise on clinical hold remediation strategies.
- Clinical team filed 20 INDs, 8 orphan drug designations, and 5 expedited pathways per year.
- Write/review protocols, ICFs, IBs, narratives, and other regulatory documents.
- Training and mentoring of the clinical team.
Clinical Research Physician - AstraZeneca - Gaithersburg, MD
(2014-12 - 2019-04)
- Lead physician of two multi-national Phase III studies in SLE.
- Investigator meeting presentation, site selection, inclusion/exclusion criteria questions.
- Lead safety and medical quality calls with CRO and sites.
- Point person for all safety-related events, lead safety submission, and CSR prototype.
- DSMB and CV adjudication committee liaison and presentations.
- Medical input on regulatory documents (protocol, ICF, IB, IRB/EC communications).
Clinical Consultant to Pharmaceutical and Device Companies (Medical-Safety Monitor) - Independent
(2010-07 - 2014-12)
- 2 Years: Phase III Diabetic Foot Ulcer study (Biological) – 30 sites, US and Canada. Document writing (IND, IB, Protocol + Amendments, CRF, Study reports...). Safety monitoring and reporting (SAE, PSUR) individual case narratives, coding, sponsor representative to DSMB, inclusion/exclusion questions from sites, CRO oversight.
- 1 Year: Phase IV Oncology studies in sarcoma, tumors of unknown origin, ovarian cancer. Study start-up activities: Protocol, CRF writing, vendor selection, investigator identification, safety plan.
- Project work in wound care, weight loss, carotid artery embolic protection, nutritional support in ICU, coronary stenting, surgical sealant.
Director, Clinical Research / Complaint Handling and Safety Surveillance - Cordis (Johnson & Johnson) - New Jersey
(2005-02 - 2010-07)
- Filed two IDEs in peripheral artery diseases.
- Medical Safety Monitor for multiple cardiovascular clinical studies (drug-eluting stents).
- SAEs & AEs causality/expectedness assist adjudication of events with DSMBs.
- Medical input and review for reports and filings to regulatory bodies.
- Medical due diligence for the new product acquisition team.
- Interact and meet with the FDA on product safety and new indications.
- Recipient of "Team Excellence Award" (July 2006) for new product launch.
- Assess the medical impact of manufacturing issues on product safety.
Director, Medical Affairs / Director, Clinical Operations, Consumer and Personal Products Worldwide - Johnson & Johnson - NJ
(2002-01 - 2005-02)
- Phase I through IV studies for NDA products in women's health and dermatology.
- Medical Safety Monitor for women's health-marketed products.
- Manage investigator relations and meetings.
- Medical due diligence for new business opportunities.
- Medical presentations for a sales force.
- Member, Healthcare Compliance Committee.
Associate Director, Clinical Research and Development - Aventis Behring - King of Prussia, PA
(2000-05 - 2002-01)
- Clinical Project Manager for fibrin sealant.
- Member Pharmacovigilance Team.
- Manage Phase III studies.
- Protocol development / CRO oversight.
- Write clinical reports for regulatory submission.
- Prepare budgets and manpower allocation.
- Oversee SAE monthly meetings.
Medical Director and Principal Investigator - South Florida Bioavailability Clinic
(1996-01 - 2000-05)
Phase I-IV studies - 100 studies were personally conducted.
- Protocol development, design, and writing.
- Ensure GCP, ICH, and FDA regulation compliance.
- AE / SAE is reporting to the sponsor and FDA.
- Personnel selection, training, and evaluation.
- Budget preparation and contract negotiation.
- Clinical study oversight and management.
- Screening and dosing of participants.
- Case report form review and design.
Medical Director, Miami Shores Office - Greater Miami Medical Center - Miami, FL
(1993-09 - 1995-07)
- Direct patient care in office, hospital, and nursing home settings.
