Chief Medical Officer

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 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 lifethreatening 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 worlds 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
The Chief Medical Officer (CMO) at Aerogen Pharma will serve as a key member of the executive leadership team of a small innovation-driven pharmaceutical company focused on transforming neonatal care. The CMO will shape the companys medical clinical and scientific strategy while contributing broadly to corporate strategy portfolio decisions company building partnering and organizational development.
As the companys senior medical leader the CMO will represent Aerogen Pharma with neonatologists investigators key opinion leaders regulators professional societies advocacy groups strategic partners investors and other stakeholders globally. Internally the CMO will provide collaborative hands-on leadership across clinical medical with strong partnership to regulatory research and commercial functions
This is a exciting opportunity with a growing company to shape organizational design and culture while transforming the future of surfactant delivery for neonatal respiratory distress syndrome globally.

What are the key responsibilities
Accountable for overall medical/clinical strategy while contributing to portfolio priorities target product profiles and major development decisions
Accountable for medical registration strategy benefit-risk pivotal evidence package and readiness for submission/approval.
Provide medical input into regulatory strategy and documentation including clinical sections of INDs NDAs/MAAs protocols investigator brochures clinical study reports and responses to health authority inquiries.
Contribute to safety oversight activities including review of adverse events risk management plans and benefitrisk assessments in collaboration with Pharmacovigilance.
Develop and deliver scientific communications such as medical presentations congress materials publications abstracts and internal training content.
Ensure all activities comply with applicable laws regulations industry codes of practice and internal policies.
Support continuous improvement of medical processes governance and standards to advance the Aerogen Pharma medical function.
Partner cross-functionally with Clinical Operations Regulatory Affairs Pharmacovigilance Commercial Market Access and R&D to deliver product-driven initiatives and ensure consistent medical messaging.
Act as a scientific resource for internal stakeholders to ensure accurate and compliant dissemination of medical information.
Accountable medical executive for Board/investor communication business development diligence and medical recommendations on major investment/go/no-go decisions.

What education and experience are required
MD with specialty in neonatalogy pulmonology adult/pediatric critical care or pediatrics with 15 years across clinical development/medical leadership including senior leadership responsibility for pharmaceutical drug/device combination development programs.
Prior leadership of at least one late-stage/Phase 3 program ideally through pivotal data readout and NDA/BLA/MAA preparation or approval. Demonstrated ability to define registrational strategy and interpret benefit-risk.
Significant direct experience with FDA and/or EMA ideally including IND/CTA EOP2/Phase 3 interactions and pre-NDA/BLA/MAA meetings.
Established credibility with investigators and KOLs in the relevant therapeutic area; experience with advisory boards steering committees publications and external scientific communication
Prior leadership across Clinical Development Clin Ops Regulatory Statistics Safety Clin Pharm and nonclinical functions. Experience building/managing teams and external development partners.
Previous exposure to executive/Board-level decision making and ability to communicate complex clinical risk and value clearly. Experience with investors partnering/BD and due diligence highly desirable for a startup CMO
Demonstrable history of making or recommending high-consequence development decisions based on incomplete clinical/scientific evidence and balancing medical regulatory operational and commercial considerations

What key skills will make you great at the role
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 companys 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.