Director, SaMD Clinical Development – Oncology AI

Bios Life; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Bios Life is seeking a Director, Clinical Development to lead the clinical strategy and evidence generation behind our SaMD portfolio — algorithm-driven, AI/ML-enabled diagnostic software in a regulated environment.

This leader owns the clinical evidence lifecycle from pre-market validation through real-world evidence, post-market performance monitoring, and ongoing algorithm surveillance, with a cross-functional, clinician-led approach.

Qualifications

• 6+ years in clinical development or related roles.
• Direct SaMD clinical development experience with AI/ML-enabled software.
• Regulatory experience with FDA/EU MDR/IVDR for software-based products.
• Experience leading multi-site validation studies with CROs/vendors.

Responsibilities

• Define and drive the SaMD clinical strategy and validation.
• Lead RWE programs, post-market surveillance, and PCCP.
• Oversee study execution from site selection to CSR.
• Collaborate with Regulatory, Data Science, and Product teams.
• Represent clinical evidence to regulators and external stakeholders.

Skills

SaMD experience

Clinical development

Regulatory strategy

RWE program design

Cross-functional leadership

Education

PhD/MD/PharmD/MS or equivalent

Job description

Bios Life is seeking a Director, Clinical Development to lead the clinical strategy and evidence generation behind our SaMD portfolio — algorithm-driven, AI/ML-enabled diagnostic software in a regulated environment.

This leader owns the clinical evidence lifecycle from pre-market validation through real-world evidence, post-market performance monitoring, and ongoing algorithm surveillance, with a cross-functional, clinician-led approach.