We develop technologies at the intersection of wearable devices, precision medicine, and life-saving therapeutics. Our first product -- funded by Google Ventures and Third Rock Ventures -- aims to redefine treatment of sudden cardiac death. Come join our growing team of engineers, successful entrepreneurs, and medical device professionals if you are interested in making a real difference in patients' lives and shaping the future of med tech in Silicon Valley.
Summary of Role:
The Vice President, Clinical Affairs will build and lead a diverse and dynamic team responsible for clinical trials/research, clinical operations, clinical data, and clinical engineering. In addition, the Vice President, Clinical Affairs will partner with cross-functional stakeholders in Engineering, Quality, Regulatory, Manufacturing and other functions to develop systems and procedures to assure uniform operation of all projects in the department. This position is accountable for all Clinical deliverables and reporting.
- Leads the group in planning, execution, and interpretation of clinical trials/research
- Oversees development, implementation and maintenance of appropriate standard operating procedures, standard work, and policies to ensure compliance with good clinical practice, global regulations, guidelines and standards for clinical studies
- Establish systems for tracking of various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
- Collaborates with Regulatory Affairs to strategize best effective approaches to clinical study designs and execution to support regulatory approvals
- Manages relationships with vendors and partners as needed for the execution of clinical trials/research
- Ensures the proper management and training of all staff and assigned CRO personnel, Associate/ Clinical Research Specialists working on research programs.
- Oversees the preparation of final reports, publications, and clinical data presentations for Regulatory submissions, conferences and study meetings.
- Routinely interacts with and reports to executive-level management on progress of Clinical Affairs programs and studies.
- Collaborates with R&D, Program Management, Regulatory Affairs and Quality Affairs on new product development (NPD) products and processes.
- Maintains an effective working relationship with premier scientists in the field, in order to monitor priorities in the field, identify outstanding questions, and to review the literature to identify policy questions, or to predict market developments.
- Keeps abreast of pertinent literature, prepares and reviews white papers, and provides education to staff as needed.
- Monitors developments in the field to assess competitive activity, market developments, and to identify opportunities to broaden service utilization.
- Review and communicate clinical needs and potential product enhancements
- Advanced Degree in scientific discipline
- A minimum of 10+ years of industry experience (cardiovascular experience a bonus), including at least 4 years of experience specifically in management of Clinical Affairs staff
- A history of building successful clinical teams in a related technical space
- Demonstrated proficiency in required software (MS Word, Excel, Outlook, Project, Power Point) and computer skills.
- Excellent interpersonal skills, strong written and verbal communication/presentation skills necessary to meet the needs of various audiences
- Must be able to travel as required for the project
- Strong team leadership experience and motivational skills
- Able to problem solve and use good judgment
- Strong program management skills