Medical Director, Clinical Operations

About Aerogen Pharma:

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.

We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world.

Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.

Join us as we embark on this breakthrough and become inspired to deliver.

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.

You will execute and oversee clinical programs across the product lifecycle, including early- and late-stage development, post-marketing activities, and real-world evidence initiatives, to support business objectives and regulatory submissions.

This role works closely with stakeholders across the business to accomplish delivery of product driven initiatives, build and develop enduring peer-to-peer relationships with healthcare professionals and institutions creating constructive, cross-functional partnerships with internal and external stakeholders. In addition, preparation of scientific presentations/talks, responsibility for internal and external medical publications, and clinical sections of regulatory documents will be a key responsibility.

• 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…