Neonatal Clinical Development Director

Aerogen; Raleigh, Northern (NC, KY); Hybrid; USD 200,000 - 320,000; Full time

Job summary

Aerogen Pharma is seeking a Medical Director, Clinical Development to lead medical strategy for our neonatal programs, including the ongoing Phase 3 trial, and ensure compliance with regulatory and ethical standards. You will partner with the CMO and Clinical Operations to design studies, oversee safety monitoring, and drive translational and regulatory activities.

You will cultivate relationships with investigators and KOLs, contribute to IND/CTA submissions, and guide cross-functional teams

Qualifications

• MD Neonatology with 5+ years leading clinical studies.
• Experience in biotech/pharma environment preferred.
• Neonatal clinical trial experience, including design and analysis.
• Preferably has served as PI or Co-PI on neonatal trials.
• Experience designing data collection tools (CRFs, study databases).
• DSMB and/or IRB/Ethics Committee experience a plus
• Leadership roles within Division, Department, or Hospital are a plus
• Experience contributing to Investigator's Brochures, protocols, CSRs and regulatory responses.
• Experience authoring clinical sections of briefing documents and regulatory submissions
• Experience with translation of pre-clinical models to clinical study and safety monitoring

Responsibilities

• Lead medical strategy for assigned development programs, translating evidence into clinical development plans and leading study design and results communication.
• Provide medical oversight of study execution, including protocol development, eligibility resolution, data review, and cross-functional decisions.
• Lead clinical and medical aspects of first-in-human development, including translational assessment, dose strategy, biomarkers, safety considerations, and IND/CTA contributions.
• Provide ongoing medical monitoring and safety oversight with Pharmacovigilance collaboration.
• Serve as the clinical SME for regulatory strategy, briefing documents, submissions, and regulatory interactions.
• Develop and maintain relationships with investigators, KOLs, healthcare institutions, and external experts.
• Build cross-functional scientific presence to enhance Aerogen Pharma’s clinical development program.
• Contribute to safety oversight activities with risk management and benefit–risk assessments.

Skills

Medical leadership

Clinical development

Regulatory strategy

Pharmacovigilance

Cross-functional collaboration

Education

Neonatology MD

Job description

Aerogen Pharma is seeking a Medical Director, Clinical Development to lead medical strategy for our neonatal programs, including the ongoing Phase 3 trial, and ensure compliance with regulatory and ethical standards. You will partner with the CMO and Clinical Operations to design studies, oversee safety monitoring, and drive translational and regulatory activities.

You will cultivate relationships with investigators and KOLs, contribute to IND/CTA submissions, and guide cross-functional teams