Director, Clinical Development; SaMD Diagnostics + Medical Device

Bios Life is a technology-enabled healthcare company built to empower individuals to proactively manage their cancer risk, redefining personalized cancer screening and survivorship.

Surveillance for people at high risk of cancer and for cancer survivors is too often generic, fragmented, and reactive. Screening follows population averages rather than individual risk. Data, expertise, and care delivery sit apart from one another, and care tends to wait for a problem to appear before responding.

Bios Life is building the operating system for personalized cancer surveillance: a platform that reads genomic, clinical, laboratory, and lifestyle data together, models how an individual’s risk changes over time, and integrates that intelligence with a continuously curated evidence base – all delivered by a clinician-led care team specialized in cancer surveillance.

We offer two programs:

Personalized Screening – an integrated pan‑cancer screening program built around an individual’s risk profile.

Survivorship – continuous surveillance and holistic care designed around the specific needs of cancer survivors.

Our team pairs decades of experience at the forefront of innovative cancer care with deep expertise in genomics and machine learning, supported by internationally recognized advisors who have helped shape screening and survivorship guidelines.

We are seeking a Director, Clinical Development to lead the clinical strategy and evidence generation behind our Software as a Medical Device (SaMD) portfolio — algorithm‑driven, AI/ML‑enabled diagnostic and device software operating in a fully regulated environment (FDA, ISO 13485/14155, IEC 62304, EU MDR/IVDR).

This leader owns the clinical evidence lifecycle for software‑based products: from pre‑market clinical validation of algorithms through real‑world evidence (RWE) generation, post‑market performance monitoring, and continuous algorithm surveillance. This is a role for a clinical development leader who understands what it takes to validate software — not just hardware or assays — and to sustain that evidence as models evolve in the field.

You will sit at the intersection of clinical science, regulatory strategy (including FDA’s SaMD / AI‑ML action plan and Predetermined Change Control frameworks), data science, and product development.

• Own the clinical development strategy for SaMD products, aligned to FDA’s SaMD framework, Good Machine Learning Practice (GMLP), and applicable international standards.
• Design and lead clinical validation studies that establish the analytical and clinical validity of algorithm/AI‑driven diagnostic and device software.
• Define clinical evidence requirements for model performance, generalizability, and subgroup/bias analyses.

• Design and execute real‑world evidence (RWE) programs — prospective registries, retrospective real‑world data (RWD) studies, and post‑market performance monitoring for deployed software.
• Establish continuous performance surveillance for AI/ML models in the field, supporting predetermined change control plans (PCCP) and algorithm update evidence.
• Leverage RWD/RWE for label expansion, reimbursement/health‑economics support, and regulatory lifecycle maintenance.

• Lead end‑to‑end study execution: site selection, start‑up, enrollment, monitoring, data lock, close‑out, and clinical study reports (CSRs).
• Manage CROs, data partners, real‑world data sources, core labs, and clinical sites — including budgets, timelines, and quality oversight.
• Oversee clinical data integrity, safety reporting, and audit/inspection readiness.

• Partner with Regulatory Affairs on FDA submissions (510(k), De Novo, PMA, IDE, Q‑sub/pre‑sub) and international filings (EU MDR/IVDR, CE mark) for software‑based products.
• Author and review clinical evaluation plans/reports (CEP/CER), clinical validation protocols, PMCF/PMPF plans, and RWE study designs.
• Ensure compliance with ICH‑GCP, ISO 14155, IEC 62304, 21 CFR 812/820, ISO 14971, and SaMD‑specific guidance.