Director of Clinical Affairs - End-to-End Device Trials

BioTalent; San Francisco (CA); Vor Ort; USD 180.000 - 250.000; Vollzeit

Zusammenfassung

BioTalent is seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This hands-on role covers concept through trial completion and post-market surveillance, requiring leadership across internal teams and external partners.

You will design studies, lead site activation and enrollment, manage IRB submissions, and ensure FDA/ICH compliance while scaling the clinical operations function for multiple regions.

Qualifikationen

• 10+ years in hands-on clinical operations for FDA-regulated devices or SaMD.
• Experience owning device/SaMD lifecycle from concept to post-market.
• Ability to design studies with internal and external stakeholders.

Aufgaben

• Own full clinical lifecycle from design to trial execution and post-market surveillance.
• Develop study designs with internal teams and external advisors.
• Lead site selection, activation, enrollment, monitoring, and close-out.
• Manage IRB submissions, informed consent, and essential documents.
• Oversee third-party sites and investigators as primary contact.
• Develop timelines, budgets, and risk mitigation for leadership.
• Ensure compliance with FDA regs, ICH-GCP, ISO 14155, SaMD guidance.
• Manage CRO relationships and vendor performance; negotiate contracts.
• Collaborate with regulatory, product, engineering, and legal teams.
• Support FDA interactions and 510(k) submissions; scale clinical ops SOPs.
• Maintain post-market surveillance including adverse event reporting.

Kenntnisse

Clinical operations

Regulatory affairs

Cross-functional leadership

FDA regulations

Vendor management

Trial design

Ausbildung

B.S. Degree

Tools

CRO management

IRB/Ethics submissions

Jobbeschreibung

BioTalent is seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This hands-on role covers concept through trial completion and post-market surveillance, requiring leadership across internal teams and external partners.

You will design studies, lead site activation and enrollment, manage IRB submissions, and ensure FDA/ICH compliance while scaling the clinical operations function for multiple regions.