SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
BigHat Biosciences is seeking a Senior Director of Clinical Operations to lead the design, execution, and management of clinical trials for early-stage biologic drugs in oncology and inflammatory diseases. This is a strategic and operational leadership role in a fast-paced biotech startup environment.
Key responsibilities include developing and executing clinical operational strategies to advance biologics from early-phase trials through regulatory approval. You will collaborate with cross-functional teams including R&D, Regulatory, CMC, and Translational Biomarkers to align clinical strategies with company objectives. You'll serve as a key stakeholder contact for investigators, regulators, and external partners, supporting regulatory interactions and inspections.
You will lead the planning, initiation, and management of Phase I–III clinical trials, ensuring compliance with ICH-GCP, FDA, and EMA standards. This includes overseeing vendor selection and CRO management, conducting site monitoring activities, and ensuring protocol adherence and data integrity. You'll monitor trial progress, manage risks, and resolve operational challenges efficiently.
The role involves close partnership with the Translational Biomarker team to ensure clinical operations infrastructure supports biomarker sample collection, handling, and logistics across trial sites. You'll oversee clinical data management activities, including data completeness, quality review, and query resolution to ensure audit-ready datasets.
Additional responsibilities include managing the preparation and lifecycle of clinical documents (protocols, ICFs, investigator brochures, clinical study reports, regulatory submissions) and developing/managing clinical operations budgets to ensure cost-effective resource allocation and timely milestone delivery.
Required qualifications: Advanced degree in life sciences, pharmacy, or related field (PhD, MD, PharmD preferred); 10+ years clinical operations experience with strong track record in oncology and/or inflammatory diseases; demonstrated ability to lead teams in startup environments; in-depth knowledge of ICH-GCP, FDA/EMA regulations, and global clinical trial processes; proven vendor management, CRO oversight, budget management, and trial risk management experience; familiarity with data management principles and clinical document generation across trial lifecycle.
