Director Clinical Operations Jobs in Raleigh, NC

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.
What is the role?
Thie 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. 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.
What are the key responsibilities?
• Lead the medical strategy for assigned programs, including the design, execution, interpretation, and communication of clinical studies.
• Support and oversee Investigator-Initiated Research (IIR) by developing scientific concepts, evaluating proposals, ensuring appropriate governance, and maintaining compliant collaboration with investigators.
• Serve as a key medical liaison to external experts, including clinical investigators, key opinion leaders (KOLs), and healthcare institutions.
• Build and sustain credible, peer-to-peer scientific relationships that enhance Aerogen Pharma's presence within the medical and scientific community.
• Plan, execute, and provide medical leadership for advisory boards, steering committees, and expert panels to drive high-quality scientific exchange and actionable insights.
• 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.
• 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 benefit-risk assessments in collaboration with Pharmacovigilance.
• Develop and deliver scientific communications such as medical presentations, congress materials, publications, abstracts, and internal training content.
• Act as a scientific resource for internal stakeholders to ensure accurate and compliant dissemination of medical information.
• 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.
What education and experience are required?
• Advanced scientific or medical degree (e.g., MD, PharmD, PhD, or equivalent).
• At least two years' experience in clinical development management, neonatology experience preferred.
• Relevant postgraduate training or experience in clinical development, medical affairs, or a related field.
What key skills will make you great at the role?
• Demonstrated expertise in clinical study design, execution, and interpretation.
• Experience managing Investigator-Initiated Research programs and governance processes.
• Proven ability to engage effectively with KOLs, investigators, and healthcare institutions.
• Strong cross-functional collaboration skills across Clinical, Regulatory, Safety, Commercial, and R&D teams.
• Experience contributing to regulatory submissions and health authority interactions.
• Knowledge of pharmacovigilance processes, risk management, and benefit-risk assessment.
• Excellent scientific communication skills, including publications and medical presentations.
• Thorough understanding of compliance requirements and industry codes of practice.
• An understanding of the compliance framework for medical interactions in relation to global and local Regulation.
• High degree of cross-functional collaboration with good leadership skills in a matrix setting
• Ability to communicate clearly information and concepts which may be complex in nature.
• Good understanding of acute care environment at Global ( US, EMEA, AP) regional and country level
• Good knowledge of pharmacovigilance and regulatory legislation
• Very good knowledge of English with good presentation 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.
What is it like to work at Aerogen?
Our purpose is to transform patient lives, and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There's something for everyone! Here is an idea of what we offer:
• Competitive bonus plan.
• Above market life insurance.
• Opportunities for development and professional growth.
• "Aerogen Connect" - our employee-led program that helps our global teams unite and have fun.
• We donate 1% of profits and time to charities and organizations.
Visit our careers website for more information about life at Aerogen.
Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at [email protected]. Please provide your name and preferred contact method.