Pharma - Senior Director of Clinical Operations

7 days ago

Raleigh, North Carolina, United States Aerogen Full time
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?
The Senior Director of Clinical Operations, reporting to the VP of Clinical Operations is responsible for compliant execution and reporting of clinical studies in critical care settings, such as NICU. We are seeking an experienced and highly motivated Senior Director of Clinical Operations to lead and oversee clinical programs from late-stage development through post-market surveillance. This position will play a pivotal role in managing Phase 3 and Phase 4 clinical trials, regulatory submissions, and the successful implementation of new IT systems to enhance clinical operations. The ideal candidate will have a proven track record in driving positive outcomes from pre-approval inspections and will be responsible for ensuring compliance with regulatory and quality standards globally.

What are the key responsibilities?

• Partner with VP clinical operations to develop and deliver clinical operations strategy and operating model.

• Manage clinical operations for Phase 3 and Phase 4 trials, ensuring that studies are executed efficiently, on time, and within budget.

• Oversee the planning, coordination, and execution of global clinical trials, including site selection, study start-up, patient recruitment, monitoring, and data management.

• Collaborate closely with cross-functional teams including Clinical Development, Regulatory Affairs, Quality Assurance, and Project Management to support BLA/NDA filings.

• Lead the preparation and submission of regulatory documents, ensuring high-quality submissions for BLA or NDA filing.

• Act as the primary point of contact during pre-approval inspections, ensuring compliance with GCP, regulatory requirements, and company standards. Drive positive outcomes from inspections by overseeing the preparation of responses and action plans.

• Implement and optimize IT systems and platforms to enhance clinical trial management, data collection, and reporting.

• Develop and manage SOPs, policies, and procedures to ensure compliance with internal and external guidelines.

• Mentor and develop clinical operations teams, providing leadership, guidance, and support to ensure high performance and professional growth.

• Track and analyze key performance indicators (KPIs) and metrics to assess the success of clinical programs and make data-driven decisions.

• Stay up-to-date with industry trends, regulatory requirements, and best practices to continuously improve clinical operations.

What education and experience are required?

• Advanced degree (PhD, PharmD, MD, or equivalent) preferred; a bachelor's degree in life sciences or related field required.

• Minimum of 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry, with a direct experience with Phase 3 and Phase 4 clinical trial delivery as sponsor.

• Proven experience in managing BLA or NDA filings, including successful interactions with regulatory authorities.

• Demonstrated success in leading clinical teams through pre-approval inspections with positive outcomes.

• Experience in implementing and managing new IT systems and tools for clinical trial management.

What key skills will make you great at the role?

• Strong understanding of GCP, ICH guidelines, and global regulatory requirements.

• Excellent project management skills, with the ability to manage multiple projects and priorities simultaneously.

• Strong leadership, interpersonal, and communication skills.

• Ability to work effectively in a fast-paced, dynamic environment and collaborate with cross-functional teams.

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 centralise 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 recognised and professional development is encouraged.

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