Medical Director, Clinical Development

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 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.