Senior Director, Clinical Operations

requirements and chain-of-custody standards. Translational Biomarker Support: Partner closely with the Translational Biomarker team to ensure clinical operations infrastructure supports biomarker sample collection, handling, and logistics across all trial sites. Coordinate with sites and CROs to ensure biomarker sampling plans are implemented correctly and that sample quality and completeness meet program

requirements. Data Management and Quality: Oversee clinical data management activities, including data completeness, quality review, and timely query resolution to ensure high-quality, audit-ready datasets. Implement and maintain data quality management processes in collaboration with data management and biostatistics partners. Clinical Document Generation: Manage the preparation and lifecycle of key clinical documents, including protocols, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions, ensuring accuracy, timeliness, and compliance with applicable guidelines. Coordinate cross-functional input and review cycles to deliver complete, high-quality documentation. Budget and Resource Management: Develop and manage clinical operations budgets, ensuring cost-effective resource allocation. Optimize timelines and resources to meet critical milestones and deliverables. Skills Knowledge and Expertise Advanced degree in life sciences, pharmacy, or a related field (PhD, MD, PharmD preferred). 10+ years of experience in clinical operations, with a strong track record in oncology and/or inflammatory diseases. Experience leading operational aspects of early-phase clinical trials in the biotech or pharmaceutical industry. Demonstrated ability to build and lead teams in a dynamic, startup environment. In-depth knowledge of ICH-GCP guidelines, FDA/EMA regulations, and global clinical trial processes. Proven experience in vendor management, CRO oversight, budget management, and trial risk management. Experience in clinical site-side sample management and biomarker program support. Familiarity with data management principles and data quality oversight in clinical trials. Experience managing the generation of clinical documents across the trial lifecycle. Exceptional communication, leadership, and problem-solving skills. Experience in oncology, inflammatory diseases, and/or molecularly targeted therapies. Total Rewards The salary estimated for this position is $275,000 - $295,000 +

bonus + options +

benefits.

Compensation will vary depending on job-related knowledge, skills, and experience. Actual

compensation will be confirmed in writing at the time of the offer. What BigHat Offers: Range of health insurance plan options through Anthem and Kaiser (monthly credit if benefit waived) Dental, and vision coverage through Guardian Additional well-being

benefits through Nayya, OneMedical, Wagmo, Rula, and more 401(k) with company match DTO, two weeks of company-wide shutdown, and 12 company holidays Paid parental leave

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