Scientific/Clinical Project Manager

Oragenics is a clinical-stage biopharmaceutical company developing ONP-002, a first-in-class intranasal neurosteroid therapy for mild traumatic brain injury (concussion). We are preparing an IND submission targeting Q4 2026 and are actively running a Phase IIa clinical trial in Australia. We're a small, fast-moving team and we're looking for someone who thrives in that environment.

The Role

This is a hands-on execution role. You'll be the internal owner of our nonclinical and clinical program operations — managing CRO and vendor relationships, driving study timelines, coordinating with our regulatory partners, and helping ensure our FDA submissions meet the bar. You'll report directly to the CEO and work closely with our Chief Medical Officer and external regulatory team.

This is not a role for someone who needs a large support structure. It's a role for someone who can pick up a complex program, figure out what needs to happen next, and make it happen.

What You'll Do

• Manage day-to-day relationships with nonclinical CROs, CMC vendors, and clinical trial partners
• Track study timelines and deliverables across toxicology, PK, CMC, and clinical workstreams
• Draft protocols and study-related documents for regulatory partner review
• Coordinate IND-enabling study execution and ensure deliverables are on schedule for submission
• Support FDA meeting preparation and briefing document coordination
• Flag risks early and drive resolution — internally and with vendors

What We're Looking For

• Direct, hands-on experience with an FDA IND submission — not adjacent regulatory experience; actual IND involvement
• 5+ years of clinical trial or CRO project management in FDA-regulated drug development
• Demonstrated ability to manage external vendors and hold them accountable for quality, timelines, and cost
• Comfortable operating independently in a small, resource-constrained biotech
• Strong written communication skills — you'll be drafting documents that external teams QC
• CNS, neurology, or intranasal drug delivery experience is a strong plus
• Combination drug-device product experience is a plus

Compensation

$150,000–$200,000 base, commensurate with experience. Remote-eligible. Oragenics is an equal opportunity employer.