Director, Clinical Operations

Aerogen Pharma; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Aerogen Pharma in Raleigh, NC seeks a Director of Clinical Operations to lead end-to-end clinical programs, ensuring timelines, budgets, and regulatory compliance. You will oversee study documents, vendor management, and cross-functional collaboration, driving efficiency, quality, and strategic execution in early- and late-phase trials.

The role reports to the VP of Clinical Operations and demands strong leadership, communication, and problem-solving skills to advance neonatal and critical-care

Qualifications

• Bachelor’s or master’s degree in a scientific field.
• At least 10 years in clinical operations with 3+ years in a Director role.
• Experience managing domestic and international early- and late-phase trials via CRO/vendor.
• Demonstrated leadership and team management experience.
• Excellent organizational and strategic planning skills.
• Excellent written and verbal communication skills.

Responsibilities

• Oversee clinical programs, timelines, budgets, and regulatory standards.
• Lead development of protocols, informed consent forms, study manuals, and study reports.
• Identify outsourcing needs and manage vendor/external consultant relationships.
• Develop and implement strategic plans to improve trial efficiency and quality.
• Ensure trials are conducted per ethical, regulatory, and SOP requirements.
• Coordinate with internal departments and manage clinical operations staff.
• Present progress reports to senior management and stakeholders.
• Promote a culture of quality within Clinical Operations.

Skills

Leadership

Project management

Vendor management

ICH/GCP compliance

Strategic planning

Communication

Education

Bachelor’s or Master’s degree in a scientific field

Tools

CTMS

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?

The Director of Clinical Operations is responsible for the management, oversight, and hands‑on execution of clinical programs, ensuring completion in accordance with timelines, budgets, and regulatory and corporate quality standards. This role serves as a key functional leader and subject matter expert, collaborates with other functional leads to achieve departmental and corporate objectives, and proactively improves the efficiency, effectiveness, and quality of Aerogen Pharma’s clinical trial activities. This position reports to the Vice President of Clinical Operations.

What are the key responsibilities?

• Manage and implement clinical operational functions, allocating and directing internal resources and outsourcing effectively when necessary to achieve project goals on time.
• Lead and/or participate in the development of critical study documents, including protocols, informed consent forms, study manuals, investigator brochures, and clinical study reports.
• Identify outsourcing needs and oversee vendor and external consultant selection, management, performance, and relationship maintenance.
• Develop and implement strategic plans and necessary operational changes to improve the efficiency, effectiveness, and quality of Aerogen Pharma’s clinical trial activities.
• Ensure clinical trials are conducted in accordance with ethical standards, applicable regulatory requirements, ICH/GCP requirements, corporate and departmental SOPs and policies, and industry best practices.
• Coordinate with internal departments to support the smooth and effective execution of clinical trials.
• Manage and lead clinical operations staff, including recruitment, training, guidance, mentorship, and performance evaluation.
• Maintain current knowledge of developments in clinical trial conduct and regulatory requirements.
• Generate and present clinical trial progress reports to senior management and stakeholders.
• Promote a quality culture within Clinical Operations.
• Perform other duties as assigned.

What education and experience are required?

• Bachelor’s or master’s degree in a scientific or related field.
• At least 10 years of clinical operations experience, including at least 3 years in a Director role within a pharmaceutical development environment.
• Strong experience setting up and managing domestic and international early- and late-phase clinical trials, either directly or through CRO/vendor management.
• Demonstrated leadership skills and experience managing a team.
• Excellent organizational and strategic planning skills.
• Strong problem‑solving abilities and sound decision‑making skills.
• Excellent written and verbal communication skills.

What key skills will make you great at the role?

• Proficient understanding of clinical trials and research methodologies, with the ability to plan and execute strategies aligned with the organization’s mission and vision.
• Outstanding leadership skills to motivate, engage, and enable clinical professionals to perform effectively.
• Strong problem‑solving abilities to identify and address issues that may affect clinical service delivery or patient care.
• Exceptional communication, interpersonal, and negotiation skills for working effectively with team members, stakeholders, patients, vendors, and consultants.
• Strong analytical skills to assess data, identify trends, and make informed decisions that improve clinical trial efficiency.
• Extensive knowledge of drug development functions relevant to clinical trial conduct, including data management, biostatistics, pharmacovigilance, and CMC/supply chain management.
• Excellent financial acumen to manage budgets, forecast requirements, and maintain fiscal responsibility at the study and Clinical Operations departmental levels.

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.

Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law.