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.

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.

Client 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.
• 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

• 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