Director, Clinical Operations

Role Summary

The Director/Senior Director of Clinical Operations will oversee the planning, execution, and delivery of clinical trials, initially focusing on the L606 program, ensuring alignment with corporate goals and regulatory requirements. You will lead and closely work with internal and external stakeholders to bring transformative therapies to market with this new drug device combo treatment.

Responsibilities

• Leads on clinical and operational trial deliverables at trial sites according to timelines, budget, operational procedures, quality/compliance, and performance standards.

Clinical Set-up and Execution

• 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

Clinical Trial Recruitment/Clinical Trial Health/Collaboration and Best practices

• 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.

Requirements

Education and Experience

• 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
• Highly desirable but not required: Experience supporting regulatory submissions, previous roles working as a study manager, study coordinator, research nurse, and working with rare diseases/devices.

Knowledge and Skills

• 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.

Location/Travel

• This position is remote or office-based, depending on location. Travel may be required as needed to support the assigned clinical trial/s but would not be expected to exceed 15%.

Education

• Bachelor’s degree required in the life or physical sciences.

Qualifications

• Required: Bachelor's degree in life or physical sciences
• Required: 10+ years of experience in clinical operations
• Required: Proven track record of leading global clinical trials from start-up to completion
• Required: Extensive clinical development and pharmaceutical experience with base knowledge of applicable regulations
• Required: Experience working on Phase 2-3 clinical development studies
• Preferred: Experience supporting regulatory submissions, prior roles as study manager/coordinator/research nurse, and experience with rare diseases/devices

Skills

• 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
• Conflict resolution, stakeholder collaboration, influencing with and without authority, and negotiation.

Additional Requirements

• Travel may be required up to 15% for the assigned clinical trial(s).