Senior Director, Clinical Operations

Key Responsibilities

• Develop and execute clinical operational strategies to advance biologics for oncology and inflammatory diseases from early-phase trials to regulatory approval.
• Collaborate with cross-functional teams (e.g., R&D, Regulatory, CMC, Translational Biomarkers) to align clinical strategies with overall company goals.
• Provide insights into trial design, site selection, and patient recruitment strategies.
• Serve as a key point of contact for internal and external stakeholders, including investigators, regulators, and partners; prepare for and support regulatory interactions and inspections.

• Lead the planning, initiation, and management of clinical trials (Phase I–III), ensuring they are conducted on time, within budget, and in compliance with global regulatory standards (ICH-GCP, FDA, EMA) and company SOPs.
• Oversee vendor selection and management, including CROs, labs, and other external partners; conduct and manage CRO site monitoring activities to ensure protocol adherence and data integrity.
• Monitor trial progress, manage risks, and resolve operational challenges efficiently.
• Oversee clinical site-side sample management, including collection, processing, storage, and shipment of biological samples in alignment with protocol requirements and chain-of-custody standards.

• 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.

• 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.

• 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.

• 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

• 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

About
BigHat Biosciences designs safer, more effective biologic therapies for patients using machine learning and synthetic biology. BigHat integrates a wet lab for high-speed characterization with machine learning technologies to guide the search for better antibodies. We apply these design capabilities to develop new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases.BigHat is a Series B biotech outside San Francisco with a team-oriented, inclusive, and family-friendly culture. Our broad pipeline of wholly-owned and partnered therapeutic programs span many disparate indications with high unmet need, such as cancer, inflammation, and infectious disease. BigHat has raised >$100M from top investors, including Section 32, a16z, and 8VC.