Director, Neonatal Clinical Development

Aerogen Pharma; Raleigh (NC); Hybrid; USD 250,000 - 350,000; Full time

Job summary

Aerogen Pharma Limited, a US-based clinical-stage specialty pharmaceutical company, seeks a Medical Director, Clinical Development to lead its neonatal clinical programs. You will oversee Phase 3 activities, engage with operations, sites, and investigators, and contribute to regulatory submissions and publications.

The role requires an MD in Neonatology with 5+ years leading clinical studies, strong leadership and cross-functional collaboration, and willingness to travel up to 30% within the US.

Qualifications

• MD Neonatology with 5+ years of post-fellowship clinical practice and ability to independently lead clinical studies.
• Experience in biotech/pharmaceutical environment strongly preferred.
• Neonatal clinical trial experience including design, implementation, management, and analysis.

Responsibilities

• Lead the clinical and medical strategy for assigned development programs, translating evidence into clinical development plans and guiding study design and interpretation.
• Provide medical leadership and oversight of clinical study execution, including protocol development and medical data review.
• Lead first‑in‑human development and readiness activities including translational assessment and safety considerations.
• Perform ongoing medical monitoring, safety oversight, and benefit–risk assessment in collaboration with Pharmacovigilance.
• Serve as clinical SME for regulatory strategy, briefs, submissions and interactions with health authorities.
• Develop relationships with investigators, KOLs, and healthcare institutions to inform development strategy.
• Contribute to safety oversight and risk management, including adverse events review.
• Prepare scientific presentations and internal/external publications; contribute to regulatory documents.

Skills

KOL engagement

Pharmacovigilance

Cross-functional collaboration

Leadership

Scientific/medical communications

Education

MD, Neonatology

Job description

Aerogen Pharma Limited, a US-based clinical-stage specialty pharmaceutical company, seeks a Medical Director, Clinical Development to lead its neonatal clinical programs. You will oversee Phase 3 activities, engage with operations, sites, and investigators, and contribute to regulatory submissions and publications.

The role requires an MD in Neonatology with 5+ years leading clinical studies, strong leadership and cross-functional collaboration, and willingness to travel up to 30% within the US.