Director, SaMD Clinical Development – AI Diagnostic Software

Bios Life; Massachusetts; On-site; USD 180,000 - 240,000; Full time

Job summary

Bios Life in Cambridge, MA is seeking a Director, Clinical Development to lead the clinical strategy and evidence generation for our SaMD portfolio, encompassing algorithm-driven software in a regulated setting.

This role covers pre-market validation through real-world data, post-market surveillance, and regulatory submissions, collaborating across clinical science, regulatory, data science, and product teams to ensure robust evidence for safe, effective cancer surveillance software.

Qualifications

• 6+ years in clinical development, clinical affairs, or clinical operations.
• SaMD experience with AI/ML-enabled software in a regulated setting.
• Experience supporting FDA submissions and EU MDR/IVDR requirements for software-based products.
• Proven track record leading multi-site clinical validation studies from protocol design through CSR.
• Working knowledge of ICH-GCP, ISO 14155, ISO 13485, ISO 14971, and IEC 62304.

Responsibilities

• Lead the clinical development strategy for SaMD products aligned to FDA SaMD framework and GMLP.
• Design and oversee clinical validation studies establishing analytical/clinical validity of algorithms.
• Define clinical evidence requirements for model performance, generalizability, and bias analyses.
• Design and execute RWE programs including prospective registries and post-market surveillance.
• Lead end-to-end study execution: site selection, start-up, enrollment, data lock, CSR.
• Manage CROs, data partners, real-world data sources, core labs, and sites.
• Oversee data integrity, safety reporting, and inspection readiness.
• Collaborate with Regulatory, Data Science, R&D, Quality, Product, and Commercial teams.
• Contribute to scientific publications and represent the company at conferences.
• Mentor and build a clinical development/evidence team.

Skills

SaMD (AI/ML)

Clinical development

Regulatory strategy

Study leadership

Cross-functional leadership

Vendor management

Education

Advanced degree (PhD/MD/PharmD/MS) in life sciences or engineering

Job description

Bios Life in Cambridge, MA is seeking a Director, Clinical Development to lead the clinical strategy and evidence generation for our SaMD portfolio, encompassing algorithm-driven software in a regulated setting.

This role covers pre-market validation through real-world data, post-market surveillance, and regulatory submissions, collaborating across clinical science, regulatory, data science, and product teams to ensure robust evidence for safe, effective cancer surveillance software.