This is a key leadership position with a primary responsibility for managing a pivotal clinical study of the Hemolung Respiratory Assist System. The main responsibilities of this position are to oversee the activities associated with the execution of the clinical trial, provide leadership to the project team, serve as the primary liaison for vendor/CRO communications, manage field clinical support, and lead site relationships and communications.
Proactively manage all aspects of clinical trials to anticipate and mitigate issues to increase the opportunity for success.
Provide key decision making and action oriented leadership to the US clinical trial operations (Plan, Execute, Adjust).
Ensure excellence in clinical trial management in terms of timelines, quality/compliance and budget.
Serve as a primary resource and point of communication for CRO and other vendors and manage their performance.
Serve as a key member of the Clinical Trial Management Committee (CTMC).
Provides clinical trial management consistent with applicable regulations, guidelines and policies including GCP, ISO, MDD, FDA, and other regulations.
Develop and maintain relationships with investigators, coordinators, site staff and members of the internal ALung team.
Ensure proper collection, review, and cleaning of data.
Develop project reporting structure to lead briefings for management on trial status and results.
Oversee field clinical support at US clinical trial sites.
Other pertinent duties as assigned.
This position requires:
Relevant experience developing and executing clinical trials for Class III medical devices (ICU experience a major plus).
BS degree in health science or related field, plus 10 years of related work experience, or equivalent combination of education and experience.
Demonstrable people management and clinical trial project management experience.
Strong communication skills across management, C-suite, site PIs, vendor/CRO partners
A high degree of organizational skills, autonomy, motivation, judgment, and problem-solving capabilities.
Ability to travel and work in an intensive care unit environment, including being present during clinical procedures.
Frequent travel to clinical sites, expected up to 10 days per month. Travel will be primarily within the US.
ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere V...entures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.