BigHat Biosciences

ML-guided antibody discovery and engineering

Senior Director - Clinical Operations

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeSan Mateo, CA, USANo salary listedHybrid

About the Job

Requirements

An advanced degree in life sciences, pharmacy, or a related field is required; a PhD, MD, or PharmD is preferred.
At least 10 years of clinical operations experience, 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 and 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.
Experience in oncology, inflammatory diseases, and/or molecularly targeted therapies.

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, including R&D, Regulatory, CMC, and 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 Phase I–III clinical trials, ensuring they are conducted on time, within budget, and in compliance with global regulatory standards, including ICH-GCP, FDA and EMA requirements, 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.
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 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 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.

The role: We are seeking an experienced and motivated Clinical Operations Lead to join our drug development team, focusing on early-stage clinical development of biologic drugs in oncology and inflammatory diseases. As the Director and Lead of Clinical Operations, you will oversee the design, execution, and management of clinical trials, ensuring alignment with corporate objectives and regulatory requirements. You will lead a high-performing clinical operations function, develop strategies to accelerate development timelines, and establish best practices for trial execution. This is a unique opportunity to contribute at both strategic and operational levels in a fast-paced, collaborative startup environment.

Leadership & Strategy:

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.

Clinical Trial Execution:

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.

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.

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.

About the Company

BigHat Biosciences

ML-guided antibody discovery and engineering

BigHat Biosciences designs and develops antibody therapies by combining machine learning with synthetic biology. Its Milliner platform integrates a wet-lab workflow with AI to discover, engineer, and fully characterize hundreds of recombinant antibodies each week, enabling rapid development of safer and more effective treatments for hard-to-treat diseases such as certain infections and cancers. Unlike traditional antibody discovery, Milliner provides end-to-end screening, purification, and characterization in a high-throughput, weekly workflow, speeding up the path from concept to candidate. The company differentiates itself through its integrated platform that couples ML-driven design with synthetic biology experimentation, a focus on challenging diseases, and a culture that emphasizes work-life balance. Its goal is to deliver faster, safer antibody therapies to patients by expanding access to rapid discovery and engineering capabilities for healthcare providers and patients alike.

Company size: 51-200
Company stage: Series C
Total funding: $174.3M
Headquarters: San Mateo, CA
Founded: 2019

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