CMO, Neonatal Respiratory Innovation & Strategy

Aerogen Pharma; Raleigh (NC); On-site; USD 350,000 - 700,000; Full time

Job summary

Aerogen Pharma, a US-based clinical-stage specialty pharmaceutical company, seeks a Chief Medical Officer to shape medical strategy and lead clinical development for newborn respiratory therapies. The CMO will work with neonatology experts, regulators and investors to drive pivotal programs and portfolio decisions.

The role requires an MD with 15+ years in clinical development and senior medical leadership, with demonstrated success in late-stage trials and regulatory interactions.

Qualifications

• MD with specialty in neonatology, pulmonology, adult/pediatric critical care or pediatrics with 15+ years in clinical development/medical leadership.
• Experience leading late-stage/Phase 3 programs and NDA/MAA readiness.
• Strong FDA/EMA engagement experience including IND/CTA interactions.

Responsibilities

• Set medical/clinical strategy and contribute to portfolio priorities and pivotal decisions.
• Lead medical registration strategy, risk management, and readiness for submission/approval.
• Provide medical input to regulatory strategy and documentation (INDs, NDAs/MAAs, protocols, briefs).
• Oversee safety reviews and pharmacovigilance activities with cross-functional teams.
• Develop scientific communications for presentations, congresses, publications, and internal training.
• Ensure compliance with laws, regulations, and internal policies.
• Improve medical processes, governance and standards across the function.
• Collaborate with Clinical Operations, Regulatory, Pharmacovigilance, Commercial, Market Access, and R&D.
• Act as a scientific resource for internal stakeholders and medical messaging.
• Serve as medical executive for Board/investor communications and due diligence.

Skills

Leadership

Strategic thinking

Regulatory communication

Scientific communication

Education

MD with neonatology/pediatric critical care

Job description

Aerogen Pharma, a US-based clinical-stage specialty pharmaceutical company, seeks a Chief Medical Officer to shape medical strategy and lead clinical development for newborn respiratory therapies. The CMO will work with neonatology experts, regulators and investors to drive pivotal programs and portfolio decisions.

The role requires an MD with 15+ years in clinical development and senior medical leadership, with demonstrated success in late-stage trials and regulatory interactions.