Director, AI-Driven SaMD Clinical Development

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

Job summary

Bios Life in Cambridge, MA seeks a Director, Clinical Development to lead the clinical strategy and evidence generation for our SaMD portfolio—algorithm-driven, AI/ML-enabled software in a regulated environment (FDA, ISO 13485/14155, IEC 62304, EU MDR/IVDR).

You will own the clinical evidence lifecycle from pre-market validation through real-world data, post-market surveillance, and PCCP/evidence updates, guiding regulatory submissions and cross-functional teams.

Qualifications

• Experience leading clinical development for Software as a Medical Device (SaMD).
• Background in regulated diagnostics/medical devices (FDA/EU MDR/IVDR).
• Strong knowledge of ICH-GCP, ISO 14155, ISO 13485, ISO 14971 and IEC 62304.

Responsibilities

• Lead SaMD clinical strategy and validation studies.
• Design RWE/RWD programs and post-market surveillance.
• Manage CROs, vendors, and cross-functional partners.
• Support regulatory submissions (FDA/EU) for software-based products.

Skills

SaMD

Clinical development

Regulatory experience

Study leadership

ICH-GCP

ISO 13485

FDA experience

Advanced degree

Education

Advanced degree (PhD/MD/PharmD/MS) or equivalent

Job description

Bios Life in Cambridge, MA seeks a Director, Clinical Development to lead the clinical strategy and evidence generation for our SaMD portfolio—algorithm-driven, AI/ML-enabled software in a regulated environment (FDA, ISO 13485/14155, IEC 62304, EU MDR/IVDR).

You will own the clinical evidence lifecycle from pre-market validation through real-world data, post-market surveillance, and PCCP/evidence updates, guiding regulatory submissions and cross-functional teams.