SandboxAQ
Manager of Clinical Research, AQMed
Palo Alto, California · Vp
Sponsorship not specifiedDetected 50 days ago
GCPMachine LearningData ScienceEpicClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaboration
About the role
- The team operates at the intersection of regulated medical device development and fast-paced startup innovation, with a strong emphasis on quality, scientific rigor, and patient safety.
- You will inherit a meaningful foundation - established processes and early clinical work already underway - and take it to the next level.
- We are looking for a resourceful, deeply experienced clinical operator who thrives in ambiguity and moves with urgency.
Responsibilities
- Own end-to-end execution of AQMed's clinical study portfolio, from feasibility through pivotal and across the US, Europe, and Asia.
- Develop and maintain clinical study plans, protocols, budgets, agreements, timelines
- Lead site identification, qualification, initiation, monitoring, and close-out across multi-center, multi-geography studies.
- Select, onboard, and manage external clinical consultants and/or CRO partners
- Build and sustain trusted relationships with clinical investigators, coordinators, and hospital administration at each study site.
- Drive enrollment with creativity and urgency
Requirements
- Strong working knowledge of 21 CFR Parts 812/820, ISO 14155, EU MDR.
- Exceptional organizational and program management skills - you can hold 10 moving pieces without dropping any.
- You bring proven multi-center trial leadership, global site management experience, and the judgment to make smart and data-driven decisions.
Skills
- Familiarity with FDA De Novo, SaMD regulatory pathways, and AI/ML-based medical device submissions.
- Guidance for candidates on using AI Tools in interviews https://www.sandboxaq.com/ai-in-interviews
Compensation
- Competitive base salary, performance-based incentives or bonuses (where applicable), and equity participation.
Benefits
- Work-Life Balance: Flexible paid time off, company-wide seasonal breaks, and support for flexible work arrangements that enable sustainable performance.
- Career Development: Opportunities for continuous learning and growth through on-the-job development, cross-functional collaboration, and access to internal learning and development programs.
Company info
- Opportunities for continuous learning and growth through on-the-job development, cross-functional collaboration, and access to internal learning and development programs.
- We are committed to fostering a culture of belonging and respect, where diverse perspectives are actively sought and valued.
- Our multidisciplinary environment provides ample opportunity for continuous growth - working alongside humble, empowered, and ambitious colleagues ready to tackle epic challenges.
- We are a global team that is tech-focused and includes experts in AI, chemistry, cybersecurity, physics, mathematics, medicine, engineering, and other specialties.
- At SandboxAQ, we've cultivated an environment that encourages creativity, collaboration, and impact.
Equal opportunity
- All qualified applicants will receive consideration regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.
- Accommodations: We provide reasonable accommodations for individuals with disabilities in job application procedures for open roles.
- If you need such an accommodation, please let a member of our Recruiting team know.
- Read: Guidance for candidates on using AI Tools in interviews https://www.sandboxaq.com/ai-in-interviews
Visa & Work Authorization
- ill receive consideration regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status
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