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. What is the role? 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 What are the key responsibilities? 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. Develop and maintain trusted scientific relationships with investigators, KOLs, healthcare institutions and other external experts, using external insights to inform development strategy while representing Aerogen Pharma credibly within the neonatal medical and scientific community. Build and sustain credible, peer-to-peer scientific relationships that enhance Aerogen Pharma’s presence within the medical and scientific community. Contribute to safety oversight activities, including review of adverse events, risk management plans, and benefit–risk assessments in collaboration with Pharmacovigilance. What education and experience are required? Neonatalogist (MD) with 5+ years of post-fellowship clinical practice experience with experience to independently lead clinical studies. Experience in biotech/pharmaceutical company environment strongly preferred. Neonatal clinical trial experience, including study design, implementation, management, and analysis Preferably has served as PI or Co-PI on neonatal clinical trials. Experience in designing data collection tools (case report forms, study databases) strongly preferred. Experience as DSMB and/or IRB/Ethics Committee member is a plus Experience in leadership position(s) within Division, Department, or Hospital is a plus Experience contributing to or implementing Investigator's Brochures, protocols, CSRs and responses to regulatory and/or ethics questions. Experience Authoring clinical sections of briefing documents and regulatory applications Experience with translation of pre-clinical models into clinical study, protocol and safety monitoring design. What key skills will make you great at the role? Proven ability to engage effectively with KOLs, investigators, and healthcare institutions. Knowledge of pharmacovigilance processes, risk management, and benefit–risk assessment. Thorough understanding of compliance requirements and industry codes of practice. Strong cross-functional collaboration skills across Clinical, Regulatory, Safety, Commercial, and R&D teams. Hands on, results oriented with strong initiative, accountability and willingness to take ownership and drive projects to completion. Demonstrated strategic capability and ability to see the overall, 'big' picture, along with examples of showing courage and confidence to develop, lead and implement change across disciplines. Strong written and oral communications skills. Preference for location near Raleigh, North Carolina. Candidates in San Mateo California will also be considered. Must be available for Travel within US, up to 30% of time. Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged. Job Title Medical Director, Clinical Development City Preference for location near Raleigh, North Carolina. Product approvals and set ups may vary by country. Always refer to the user instructions suppliedwith the product for full set up instructions, warnings, cautions andcontraindications. #J-18808-Ljbffr