Experience 8-12 years
Investigation T1 / HSPD-12 credentialing (or interim) favorably adjudicated by DCSA prior to start. Investigation cost is covered by the Government.
Education Bachelor's or advanced degree in life sciences, nursing, pharmacy, or a related field
Tools Argus or comparable safety database, MedWatch, MedDRA, WHO-Drug, EDMS, Microsoft Office
ABOUT THE PROGRAM
The Office of Regulatory Activities (ORA) provides regulatory and clinical support across the full life cycle of FDA-regulated medical products sponsored by the Department of Defense. This position supports ORA on site at Fort Detrick, Maryland, working alongside government scientists, clinicians, and regulatory professionals under the DHA Research and Development / USAMRDC enterprise.
THE ROLE
Lead clinical operations and drug safety surveillance for FDA-regulated trials across multiple DoD research programs. You will run cross-functional teams, own safety oversight end to end, and serve as the senior voice on clinical quality and compliance.
WHAT YOU WILL DO
- Lead a team of Clinical Trial Managers, Monitors, and Pharmacovigilance staff, setting objectives and developing performance.
- Develop and maintain product safety profiles through integrated safety surveillance and data analysis.
- Oversee collection, medical review, coding, and timely reporting of adverse events, including SUSARs and DSURs.
- Manage and communicate safety findings to Data Safety Monitoring Boards and drive implementation of their recommendations.
- Manage and monitor Phase I and II human clinical studies from startup through closeout.
- Provide clinical safety expertise for Investigator's Brochures, INDs, NDAs, and product labels.
- Develop and update SOPs; prepare for internal audits and regulatory inspections and implement CAPAs.
WHAT YOU NEED
- 8-12 years in clinical operations and pharmacovigilance, including team leadership.
- Deep working knowledge of GCP, 21 CFR 312, and ICH guidelines.
- Hands-on experience with safety databases such as Argus and with MedWatch reporting.
- Track record managing Phase I/II trials end to end.
- Willingness to take on-call rotation for new serious adverse events.
NICE TO HAVE
- Experience with DoD or other government-sponsored trials.
- Prior DSMB coordination experience.
Pay: From $130,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person
