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. About the Role 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. Key Responsibilities SaMD Clinical Strategy & Validation 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. Real-World Evidence & Post-Market Performance (differentiating strength) 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. Study Execution & Operations 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. Regulatory & Evidence Generation 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. Cross-Functional Leadership Serve as the clinical voice on cross‑functional teams (Data Science/ML, R&D, Regulatory, Quality, Product, Commercial). Engage KOLs, investigators, Clinical Events Committees (CECs), and Data Safety Monitoring Boards (DSMBs); represent clinical and real‑world evidence to internal leadership, regulators, and external stakeholders. Build and maintain strategic relationships with leading academic institutions, clinical investigators, and industry partners to support clinical development initiatives, collaborative research, and evidence generation. Contribute to scientific publications in peer‑reviewed journals and represent the company at major medical, scientific, and clinical conferences through presentations, panels, and other thought leadership activities. Mentor and, over time, build a clinical development/evidence team. Required Qualifications Level: 6+ years in clinical development, clinical affairs, or clinical operations. SaMD (required): Direct clinical development experience with Software as a Medical Device — AI/ML‑enabled, algorithm‑driven, or digital diagnostic/device software in a regulated setting. Candidates whose entire background is hardware‑only or assay‑only, with no software/algorithm clinical validation, will not qualify. Industry: Diagnostics/IVD, medical device, or digital health, in a regulated (FDA / EU MDR / IVDR) environment. Regulatory fluency: Experience supporting FDA (510(k), De Novo, PMA, IDE, pre-sub) and/or EU MDR/IVDR clinical requirements for software‑based products; familiarity with FDA's SaMD / AI‑ML framework. Study leadership: Proven track record leading multi‑site clinical validation studies from protocol design through CSR, including CRO/vendor and site management. Standards: Working command of ICH‑GCP, ISO 14155, ISO 13485, ISO 14971, and (preferred) IEC 62304 for software lifecycle. Education: Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a life sciences, clinical, data science, or engineering discipline preferred. Location: Based in or commutable to Cambridge, MA. Preferred Qualifications Real‑world evidence (strongly preferred): Hands‑on experience designing and executing RWE/RWD programs — registries, real‑world validation, post‑market performance monitoring, or algorithm surveillance for deployed software. Experience working within oncology is strongly preferred. Experience with predetermined change control plans (PCCP) and evidence for AI/ML model updates. Exposure to companion diagnostics (CDx), digital pathology, imaging AI, clinical decision support, or precision‑medicine software. Reimbursement/health‑economics evidence generation and label‑expansion studies. Experience at a growth‑stage or scaling organization building clinical/RWE infrastructure and processes. #J-18808-Ljbffr Bios Life