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Senior Director, Clinical Operations
Job Location:
Job Location:
San Mateo, CA - USA
Monthly Salary:
$ 275000 - 295000
Monthly Salary:
Posted:
19 July 2026 (30+ days ago)
Posted:
Application Deadline:
16 October 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 IIII) 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 $275000 - $295000 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
Required Experience:
Exec
About Company
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 desig ... View more
