Director Clinical Operations

• Provide leadership and expert oversight of clinical studies including project planning, budget, resource management and contract research organization negotiation and management
• Contributes to clinical development plans and ensures alignment to business and regulatory strategies
• Act as a cross-functional liaison between clinical operations and product development teams and ensures effective alignment regarding plans, requirements, and deliverables
• Manages all aspects of study progress from start-up to close-out activities adhering to intended timelines to achieve study goals while ensuring compliance with ICH/GCP, MDR and ISO-14155 guidelines, regulatory requirements, and SOPs
• Oversees and manages CROs, vendors, and internal staff to ensure successful conduct of the clinical trial including being the point of contact for issue escalation and resolution
• Contributes to individual and team development through training initiatives, team building activities and mentoring and training of junior staff members
• Writes and/or reviews Standard Operating Procedures (SOPs) for the Clinical Operations Department including study or site related documentation
• Promotes and develops corporate initiatives for the Clinical Operations Department

Requirements

• Minimum RN or Bachelor's degree in a scientific discipline
• Proven track record in managing clinical operations activities and staff
• 8+ years of experience leading multiple global cross-functional clinical studies (Phases 1 -2, Phase 3 preferred) and vendors. Therapeutic medical device early development experience highly desired.
• Respiratory and/or cardiovascular experience preferred
• An understanding of and experience in the drug and medical device development process is required including: clinical program management, drug safety surveillance and reporting requirements, global regulatory reporting requirements, clinical study report requirements.
• Working knowledge of ICH/GCP, ISO-14155, FDA, MDR, and EU Regulations, as applicable
• Excellent team player with a proven track record in establishing working relationships with individuals from a broad range of backgrounds on cross-functional teams
• Proven track record in managing, motivating and engaging with clinical staff
• Advanced knowledge of the principles of project management, statistical data analysis and interpretation
• Able to distill complex information from multiple sources and draw meaningful conclusions and insights
• Represent the company with a high level of integrity and professionalism
• High level of initiative and ability to work independently; self-motivated and achievement driven.
• Ability to handle and prioritize multiple assignments in a fast-paced environment with changing priorities and meet deadlines and milestones
• Strong verbal and written communication skills and adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with cross-functional teams, stake holders and external vendors.
• Extensive computer skills and use of Microsoft Office applications, including proficiency in MS Project. Requires strong word processing skills.
• Ability to travel (domestically and internationally) up to 25%