VP/Director of Clinical Development
Redwood City, CA, USA · Remote
Posted on Friday, June 30, 2023
Oversee clinical and regulatory affairs of the company’s AI-based Computer-Aided Detection (CADe) research and development programs.
- Craft clinical development strategy and execute on all clinical programs
- Lead diverse and dynamic team of clinical operators, statisticians, regulatory specialists and others.
- Develop clinical trial protocols by working closely with our Chief Medical Officer
- Lead and implement clinical trials, feasibility studies, including establishing systems for tracking of various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
- Collaborate with development engineers, marketing, and business development to establish product roadmaps and timelines.
- Oversee the preparation of final reports, publications, and clinical data presentations for Regulatory submissions, conferences and study meetings.
- Oversee 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
- Accountable for all clinical deliverables, reporting and financial budgets related to clinical and regulatory affairs
- Must have experience overseeing medical device clinical development programs
- Experience with Class II and/or Class III submissions, must have recently cleared and helped commercialize a Class II and/or Class III medical device
- A minimum of 10+ years of industry experience (gastrointestinal disease experience a bonus), including at least 4 years of experience specifically in management of Clinical Affairs staff
- Salary, bonus & stock options. To be discussed.
- Location preferences: Northern California or Southern California (personnel in both regions). Open to work remotely with semi-regular face-to-face team meetings.