The VP, Clinical Affairs will provide leadership, guidance, and direction to clinical team. This key member will plan and execute clinical trials while ensuring compliance with applicable regulations, standards and procedures, company SOPs, and project plans and timelines.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required to perform this job effectively.
- Responsible for developing and overseeing the research strategy and agenda for the Clinical Affairs department.
- Responsible for overseeing the design, implementation and reporting of clinical trials that meet the highest standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfying corporate goals for study completion and reporting.
- Assist regulatory affairs with completion of required regulatory reports for the FDA, and regulatory agencies outside the US. This will also include overseeing annual clinical literature review updates.
- Plan and execute clinical trials while ensuring compliance with applicable regulations, standards and procedures, company SOPs, project plans and timelines.
- Full management for clinical trials - data analysis, monitoring, in person management, manuscript writing
- Supervises the development of protocol, implementation, and management of the process.
Projects and Other Duties:
- Experience developing educational strategies and conducting clinical trials
- Knowledge of current and new healthcare industry trends, technologies, competitors, and place in the market
- Knowledge in women’s health and experience with physicians in FPMRS, Urology and Colo-rectal surgery
- Demonstrates a continuous desire to understand, learn and implement industry best practice and trends
- Strong leadership and communication skills
- High-performer and results driven
- Ability to foster strong relationships with internal and external stakeholders
- Personifies Axonics’ Mission, Vision, and Values
- BA or BS degree in a health-related field
- Master's degree preferred
- Minimum 6 years healthcare experience
- Minimum 5 years of medical device experience
Aligning our overall business objectives with performance and merit based pay, Axonics offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. At Axonics, our employees come first!
For California, the base pay range for this position is $250,000 to $290,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Axonics is an Equal Opportunity Employer, included protected Veterans and individuals with disabilities.