The Director, Clinical Studies will oversee all clinical studies conducted at Nuvaira. The Director will ensure studies are managed and conducted in compliance with the regulations, clinical sites are managed properly, communications are compliant with the regulations, and the clinical data is of high quality. The Director will manage a team of clinical research associates, safety specialists, monitors, and consultants who will be executing multi-national clinical studies. The Director will play an essential role in maintaining positive working relationships with our US and European clinical sites, investigator physicians, CRAs, and ensure that the Nuvaira clinical department is regarded as highly responsive to their needs. The Director will ensure positive cross-functional relationships with other Nuvaira departments.
- Ensure studies are managed and conducted in compliance with the regulations, clinical sites are managed properly, communications are compliant with the regulations, and clinical data is of high quality
- Aid with global regulatory submission strategies related to clinical research
- Oversee and/or manage clinical independent oversite committees such as Data Monitoring Committee and Clinical Events Committee
- Support analysis and critical review of development reports, presentations used for strategic planning, medical safety review or submission to governing bodies; provide critical review of clinical manuscripts
- Support development of study design and protocols
- Lead continuous improvement teams to identify opportunities for greater operational efficiency and scalable solutions to improve overall clinical trial execution and scientific integrity
- Ensure clinical standard operating procedures are compliant and appropriate
- Implement strategy to identify, monitor and resolve clinical program/trial issues
- Manage a team of employees dedicated to the collection, analysis and reporting of clinical study outcomes related to the use of the Nuvaira product across different markets
- Delegate meaningful responsibilities to team members and provide the support necessary to allow them to succeed and grow professionally
- Work collaboratively with other Nuvaira departments in an effective and transparent manner to ensure corporate program timelines are met
- Lead by example to encourage others to prioritize activities and timelines to prevent patient enrollment or clinical site delays
- Work cross functionally with the finance department on contract negotiations with clinical study vendors and oversee performance to ensure maximum value and engagement
- Engage in department’s strategic planning process, prepare and manage study related budgets and headcount management
- Ensure that the Nuvaira clinical team is perceived to be helpful and highly responsive to the questions and challenges faced by our clinical sites
- Attend scientific meetings/conferences and engage personally with physicians and CRA’s
- Willingness to visit clinical sites to directly help solve problems, enhance clinical excellence, and enhance mutual respect
- Bachelor’s Degree in biological sciences or another relevant medical/scientific field
- 15+ years of direct hands-on experience supporting clinical research in the medical/scientific area
- 10+ years direct people management experience
- Strong knowledge and experience with ICH Good Clinical Practice (GCP), 21CFR 11, 50, 54, 56 and 812, ISO 14155, Declaration of Helsinki, 45 CFR 46, and any local regulations
- Experience overseeing class III medical device clinical trials
- Broad range of clinical trial experience across all phases of research
- Face-to-face FDA exposure negotiating IDE, PMA or 510Ks
- Demonstrated ability to easily form strong professional relationships based on mutual respect with a broad array of professionals including physicians, scientists, CRAs and internal colleagues.
- Strategic planning, financial modeling for clinical trials and budgeting experience
- Empowers team, able to delegate successfully
- Strong people management skills to lead, motivate, select, retain, develop and coach
- Strong analytical skill, including ability to interpret data and draw conclusions from relevant work at hand
- Strong track record of execution and delivery of results with high attention to detail
- Ability to manage multiple complex tasks and demonstrate flexibility
- Working knowledge of EDC platforms and programming
- Willingness to travel (10%)
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.