Director, Clinical Operations

Liquidia•,

1d•Hybrid

About The Position

The Director, Clinical Operations will oversee the planning, execution, and delivery of clinical trials, initially focusing on our Yutrepia program, ensuring alignment with corporate goals and regulatory requirements. You will lead and closely work closely with internal and external stakeholders to bring transformative therapies to market with this new drug device combo treatment. The successful candidate will have extensive global clinical trial operational experience, an understanding of study set-up process and a deep understanding of patient pathways and trial recruitment. Proven expertise in setting up and executing a global, controlled trial in rare disease/device is critical. Engaging, building, and maintaining excellent working relationships with CROs and other vendors with critical oversight to help development and budgetary timelines is essential for this role.

Requirements

Bachelor’s degree required in the life or physical sciences.
10+ years of experience in clinical operations
Proven track record of leading global clinical trials from start-up to completion
Extensive clinical development and pharmaceutical experience with a base knowledge of the applicable regulations.
Experience working on Phase 2-3 clinical development studies.
Experience working in a fast-paced, innovative environment
Proficiency in Microsoft Office suite, basic computer and typing skills, and tools/systems for managing clinical trials.
Strong written and verbal English communication and presentation skills.
Excellent communication, collaboration and problem-solving skills.
Skilled at conflict resolution, collaborating with stakeholders with varying viewpoints, influencing with and without authority, and negotiation.

Nice To Haves

Experience supporting regulatory submissions
Previous roles working as a study manager, study coordinator, research nurse
Working with rare diseases/devices

Responsibilities

Leads on clinical and operational trial deliverables at trial sites according to timelines, budget, operational procedures, quality/compliance, and performance standards.
Lead the strategy, planning, and execution of pivotal global clinical trials, ensuring quality, timeliness, and budget compliance.
Manage and mentor a growing clinical operations team, fostering a culture of excellence and accountability, including identification of ongoing resource needs over the lifecycle of a study.
Oversee selection and management of CROs, vendors, and clinical sites.
Develop and maintain clinical trial budgets, timelines and resource plans.
Collaborate closely with regulatory, medical, biometrics and CMC teams to ensure cross-functional alignment.
Ensure adherence to GCP, ICH guidelines, SOPs, and all applicable regulatory requirements.
Drive operational excellence through continuous process improvement and innovation.
Participate in clinical development strategy and contribute to regulatory submissions.
Oversees and tracks patient recruitment for sites, proactively identifying ways to prevent delays.
Supports the development of recruitment and retention plans in collaboration with regional CSM, oversight team and CRO.
Reports local site situations and provides insights on recruitment challenges and solutions to regional personnel including regional clin ops, OSM and other members of the team.
Oversees the activities of global and local CRO teams to ensure effective sponsor oversight of monitoring activities.
Identifies trial issues and opportunities proactively, seeks solutions, and escalates them to the appropriate team members and management and leadership teams.
Collaborates with members of the Liquidia clinical and medical teams to share best practices and beneficial experiences.
Supports CRAs and local CRO team members to aid trial delivery and compliance.