职位描述
POSITION SUMMARY: We are seeking a Director, Clinical Science to architect trial strategies and protocol execution for our oncology molecular diagnostics portfolio, with a dedicated focus on signal Studies and pipeline expansion. This clinical leadership role shapes the data validation pipeline for our cell-free DNA (cfDNA) technology, transforming population scale genomic profiles into standard-of-care screening benchmarks. Reporting directly to the Senior Director of Clinical Science, you will lead the strategic alignment and tactical delivery of early and late-stage oncology diagnostics protocols. Operating with an active builder mindset, this position co-develops clinical program strategy and drives collaborative execution across clinical development, clinical operations, biostatistics, and translational data science teams. PRIMARY RESPONSIBILITIES: Trial Strategy and Protocol Architecture Design robust clinical study concepts, specifying overall design parameters, schedules of assessments, trial objectives, clinical endpoints, and patient eligibility criteria Lead clinical development activities and protocol design for oncology Signal Studies and portfolio development Collaborate cross-functionally to author clinical study protocols, informed consent documents, and technical amendments for internal governance review Deliver technical protocol validation training to internal teams and contract research organizations (CROs), and guide case report form (CRF) layout configurations Ensure study manuals conform directly to protocol specifications and engage primary clinical investigators during initial trial design phases Data Interrogation and Cross-Functional Alignment Synthesize protocol requirements from investigators, clinical partners, and regulatory bodies, resolving conflicting operational priorities by anchoring team alignment strictly in data Partner with cross-functional technical teams to execute clinical programs within exact scope, regulatory compliance, budget, and timeline boundaries Serve as the authoritative clinical science representative across technical milestones and external clinical collaborations Lead the development of trial execution timelines and deliver unvarnished study status updates to senior leadership Lead rigorous clinical data review loops to interrogate datasets for specific validation trends, anchoring trial data cleanliness directly in empirical scientific evidence Collaborate with data management teams to write Data Review Plans, track trial outliers, and audit CRF schemas to confirm absolute data fidelity
立即申请
发布时间 2026/7/8