The Role
Lead and execute clinical operations for early- to late-phase biologics trials in oncology and inflammatory diseases. Develop strategy, manage CROs and vendors, oversee site sample and biomarker logistics, ensure regulatory compliance (ICH-GCP, FDA/EMA), supervise data quality and clinical document generation, manage budgets and risks, and collaborate cross-functionally to accelerate development timelines.
Summary Generated by Built In
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.
Key Responsibilities
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.
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:
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
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.
Skills Required
- Advanced degree in life sciences, pharmacy, or related field
- PhD, MD, or PharmD
- 10+ years of experience in clinical operations
- Experience leading operational aspects of early-phase clinical trials (Phase I-II) in biotech or pharma
- Strong track record in oncology and/or inflammatory diseases
- Demonstrated ability to build and lead teams in a startup environment
- In-depth knowledge of ICH-GCP, FDA and EMA regulations and global clinical trial processes
- Experience in vendor management and CRO oversight, including site monitoring
- Experience in clinical site-side sample management and biomarker program support
- Familiarity with clinical data management principles and data quality oversight
- Experience managing preparation of clinical documents (protocols, ICFs, IBs, CSRs, regulatory submissions)
- Proven budget management and trial risk management experience
- Exceptional communication, leadership, and problem-solving skills
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The Company
What We Do
BigHat’s mission is to improve human health by making it far easier to design advanced, next-generation antibody therapeutics. Our AI-enabled experimental platform integrates a high-speed characterization or “wet” lab with machine learning technologies to speed the antibody engineering process. When applied, these design capabilities have the potential to drive the development of new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases. BigHat is backed by Section 32, Andreessen Horowitz, 8VC, Amgen Ventures, Bristol Myers Squibb, Quadrille, Grids Capital, AME Cloud Ventures, Innovation Endeavors and Gaingels.
