Medical Director, Neonatal Clinical Development

Aerogen Pharma Limited

Northern (KY)

Hybrid

USD 180,000 - 240,000

Full time

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Benefits offered by this job

Travel flexibility

Job summary

Aerogen Pharma Limited is seeking a Medical Director, Clinical Development to lead medical strategy for its Phase 3 neonatal program. Reporting to the CMO, you will provide clinical leadership across study design, execution and safety oversight, engaging with investigators, sites, and vendors to drive regulatory submissions and publication efforts.

Preference for Raleigh, NC area, with consideration for San Mateo, CA.

Qualifications

Neonatologist physician with board/certification and post-fellowship practice.
Experience in biotech/pharma settings preferred.
Neonatal trial design, management and analysis experience.
Experience as PI/Co-PI on neonatal trials is a plus.
Experience designing data collection tools (CRFs, study databases).
DSMB/IRB/ethics knowledge is beneficial.
Leadership roles in divisions/hospitals are a plus.

Responsibilities

Lead medical strategy for development programs and translate evidence into plans.
Oversee protocol development, data review and multi-function decision making.
Guide first-in-human development and IND/CTA readiness.
Monitor safety signals and risk–benefit assessments with Pharmacovigilance.
Contribute to regulatory strategy, briefing documents and submissions.
Build strong relationships with investigators, KOLs and healthcare institutions.
Prepare scientific publications and regulatory documents as required.
Travel within US up to 30%.