Medical Director, Clinical Development

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination products.

At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life-threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients.
We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities.
Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries.

This Medical Director, under the direction of the Chief Medical Officer (CMO), provides medical and scientific leadership for Aerogen Pharma’s clinical development programs, ensuring alignment with corporate strategy and compliance with all regulatory, ethical, and scientific standards.
This role will have direct medical oversight with our ongoing Phase 3 clinical program, with engagement with internal clinical operations team, site and country level principal investigators, study coordinators, respiratory therapists and all associated vendors. In addition, this role will contribute to the design and execution of the synthetic surfactant global clinical development program

• Lead the clinical and medical strategy for assigned development programs, translating scientific and pre-clinical evidence into clinical development plans and providing medical leadership for study design, execution, interpretation and communication of results.
• Provide medical leadership and oversight of clinical study execution, including protocol development and implementation, eligibility and clinical issue resolution, medical data review, and cross-functional decision-making, in close partnership with Clinical Operations and other functions.
• Lead the clinical and medical aspects of first-in-human development and readiness, including translational assessment, dose and escalation strategy, stopping criteria, biomarkers, safety considerations, protocol development, and clinical contributions to IND/CTA submissions.
• Provide ongoing medical monitoring and clinical safety oversight, including review of emerging safety and efficacy data, identification and escalation of potential trends or signals, and assessment of evolving benefit–risk, in close collaboration with Pharmacovigilance.
• Serve as the clinical subject-matter expert for assigned programs, leading medical and clinical contributions to regulatory strategy, briefing documents, submissions, regulatory interactions and responses to health authorities.
• Develo…