Neonatal Clinical Development Director

Aerogen Pharma; North Carolina; On-site; USD 210,000 - 320,000; Full time

Job summary

Aerogen Pharma is seeking a Medical Director to provide medical and scientific leadership for clinical development programs, ensuring alignment with strategy and regulatory standards. The role includes oversight of ongoing Phase 3 and engagement with internal teams, investigators and vendors to design and execute global programs.

Responsibilities span early to late development, post‑marketing activities, and real‑world evidence initiatives, with cross‑functional collaboration and publication

Qualifications

• Neonatologist (MD) with post‑fellowship clinical practice experience and ability to independently lead clinical studies.
• Experience in biotech/pharmaceutical company environment preferred.
• Neonatal clinical trial experience including study design, implementation, management and analysis.
• Experience as PI/Co‑PI on neonatal trials is a plus.
• Experience designing data collection tools (case report forms, study databases).
• Experience as DSMB and/or IRB/Ethics Committee member is a plus; leadership positions within Division/Department/Hospital are a plus.
• Experience contributing to Investigator's Brochures, protocols, CSRs and regulatory responses.
• Experience authoring clinical sections of briefing documents and regulatory applications; translating pre‑clinical models into clinical studies.

Responsibilities

• Lead the clinical and medical strategy for assigned development programs, translating evidence into development plans and providing medical leadership for study design and results interpretation.
• Provide medical leadership and oversight of clinical study execution, including protocol development, eligibility decisions, data review, and cross‑functional decision-making.
• Lead first‑in‑human development activities, including translational assessment, dose/escalation strategy, stopping criteria, biomarkers and safety considerations for IND/CTA submissions.
• Provide ongoing medical monitoring and safety oversight, including review of emerging data and benefit–risk assessment in collaboration with Pharmacovigilance.
• Serve as the clinical subject‑matter expert for regulatory strategy, briefing documents, submissions, and regulatory interactions with health authorities.
• Develop and maintain trusted scientific relationships with investigators, KOLs, healthcare institutions and external experts to inform development strategy.
• Build peer‑to‑peer scientific relationships to enhance Aerogen Pharma’s presence in the medical community.
• Contribute to safety oversight activities including adverse events review, risk management and benefit–risk assessments.

Skills

Clinical trial leadership

Regulatory documentation

Cross-functional collaboration

KOL engagement

Travel readiness

Education

Neonatology MD (with fellowship)

5+ years post‑fellowship clinical practice

Tools

Case report forms

Study databases

DSMB/IRB engagement

Job description

Aerogen Pharma is seeking a Medical Director to provide medical and scientific leadership for clinical development programs, ensuring alignment with strategy and regulatory standards. The role includes oversight of ongoing Phase 3 and engagement with internal teams, investigators and vendors to design and execute global programs.

Responsibilities span early to late development, post‑marketing activities, and real‑world evidence initiatives, with cross‑functional collaboration and publication