Position Summary:

The Director/Sr. Director, Clinical will provide strategic direction for all clinical activities in support of US and global regulatory approval and ongoing marketing of Nuvaira products and assure that Clinical strategies and activities are developed, implemented, and maintained in support of corporate goals and objectives. The Director/Sr. Director will ensure clinical studies are managed and conducted in compliance with all applicable regulations and best practices, that clinical sites are managed to the highest standards, and that the collection and management of clinical data is of high quality. The Director/Sr. Director will manage a team of clinical research associates, safety specialists, physician-based committees, vendors and consultants who will be executing the FDA pivotal and future multi-national studies. The Director/Sr. Director will build and maintain positive working relationships with our investigator physicians and clinical site teams to ensure that the Nuvaira clinical department is regarded as highly responsive to their needs. The Director/Sr. Director will ensure positive and collaborative cross-functional relationships with other Nuvaira departments.

Key Responsibilities:

• Ensure clinical studies are managed and conducted in compliance with all applicable regulations and best practices, that clinical sites are managed to the highest standards, and that the collection and management of clinical data is of high quality
• Support US and global regulatory submissions to optimize commercial opportunities for the dNerva products
• Oversee and/or manage clinical independent oversight committees such as Data Monitoring Committee and Clinical Events Committee
• Execute critical review of development reports, presentations used for strategic planning, medical safety review or submission to governing bodies, and clinical manuscripts
• In collaboration with Nuvaira’s regulatory affairs function, develop and execute PMA panel preparations for US regulatory approval of the dNerva products
• Support development of future study design and clinical as well as post-market study protocols
• Identify and implement opportunities for greater operational efficiency and scalable solutions to improve overall clinical trial execution
• Manage a team of employees dedicated to the collection, analysis and reporting of clinical study outcomes
• Work cross functionally and collaboratively with other Nuvaira departments in an effective and transparent manner
• Manage performance of clinical study vendors to ensure maximum value and operational efficiency
• Develop high proficiency in all matters relating to the clinical trial protocols and study execution to serve as a trusted resource for our physician investigators
• Participate as a member of Nuvaira’s Executive Committee, including presentation of clinical trial updates at company and board meetings as directed by the CEO

Qualifications:

• Bachelor’s Degree in biological sciences or another relevant medical/scientific field
• 10+ years of direct hands-on experience supporting clinical research in the medical/scientific area
• 5+ 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 local regulations
• Experience overseeing class III medical device clinical trials, including panel preparation
• Broad range of clinical trial experience across all phases of research
• FDA experience negotiating IDE, PMA or 510Ks
• Travel: up to 20%

Preferred Qualifications:

• 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
• Strong people management skills
• Strong analytical skills, including ability to interpret data and draw conclusions
• Working knowledge of EDC platforms and programming
• Knowledge of / experience with cardio-pulmonary device therapies and trials is a plus

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 accommodation 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.

Apply by sending your resume to hr@nuvaira.com