Senior Director, Clinical Operations

Position Overview

We are actively searching for a dedicated and experienced Senior Director to lead Clinical Operations within our drug development team. This role centers on pioneering early-stage clinical trials focused on biologic drugs targeting oncology and inflammatory diseases. The incumbent will be responsible for designing, implementing, and managing clinical trials while ensuring compliance with regulatory standards and alignment with company objectives. The position demands leadership of a high-performing clinical operations team, development of strategies to accelerate clinical development timelines, and establishment of best practices for efficient trial execution. This role is suited for someone seeking to impact both the strategic direction and day-to-day operations within a dynamic, collaborative startup environment based in San Mateo, CA, with onsite work required.

Responsibilities

• Create and implement clinical operational strategies to advance biologic therapies for oncology and inflammation from early trial phases through regulatory approval.
• Collaborate with interdisciplinary groups including R&D, Regulatory Affairs, CMC, and Translational Biomarker teams to ensure clinical approaches align with organizational goals.
• Provide expert advice on trial design, site selection, and recruitment methods to optimize patient enrollment.
• Act as a principal liaison with multiple stakeholders such as investigators, regulators, and partners, and assist in preparing for regulatory communications and inspections.
• Oversee planning, initiation, and supervision of Phase I through Phase III clinical trials ensuring on-time, on-budget delivery consistent with ICH-GCP, FDA, EMA, and company SOPs.
• Manage vendor relationships including CROs, laboratories, and external collaborators, ensuring monitoring activities uphold protocol compliance and data integrity.
• Continuously track trial progress, identify potential risks, and rapidly address operational challenges.
• Supervise clinical site sample management, ensuring adherence to protocol for biological specimen collection, processing, storage, and shipment with proper chain-of-custody.
• Support Translational Biomarker initiatives by ensuring operations infrastructure supports biomarker sample logistics and quality control across trial sites.
• Direct clinical data management efforts to maintain comprehensive, high-quality data sets ready for audits.
• Ensure accurate preparation and maintenance of essential clinical documents including protocols, informed consents, investigator brochures, study reports, and regulatory filings.
• Develop and monitor clinical operations budgets optimizing resource use to meet critical timelines and deliverables.

Qualifications

• Advanced degree in life sciences, pharmacy, or related disciplines (preferably PhD, MD, or PharmD).
• Extensive experience (over 10 years) in clinical operations within oncology or inflammatory disease areas.
• Proven leadership in managing early-phase clinical trials in biotech or pharmaceutical settings.
• Experience establishing and guiding operational teams in fast-paced startup environments.
• Comprehensive understanding of ICH-GCP, FDA, EMA regulations, and global clinical trial procedures.
• Strong background in vendor management, CRO oversight, budgeting, and risk mitigation for clinical trials.
• Knowledgeable in clinical site-side biological sample management and biomarker program support.
• Familiarity with clinical data management processes and quality assurance.
• Competence in generating clinical trial documentation throughout the study lifecycle.
• Excellent communication, leadership, and analytical problem-solving capabilities.
• Experience with molecularly targeted therapies is advantageous.

Compensation and Benefits

The anticipated salary range is $275,000 to $295,000 annually, supplemented by performance bonuses, stock options, and comprehensive benefits. Total compensation will be tailored based on qualifications and validated upon offer.

• Health insurance choices via Anthem and Kaiser, including a monthly allowance if benefits are waived.
• Dental and vision insurance through Guardian.
• Additional wellness services such as access to Nayya, OneMedical, Wagmo, and Rula.
• 401(k) with employer match program.
• Dynamic time off policy, including company-wide shutdown weeks and recognized holidays.
• Paid parental leave benefits.

Company Overview

We are a biotech company integrating cutting-edge machine learning and synthetic biology to engineer safer and more effective biologics, primarily focusing on challenging diseases such as cancer, inflammatory disorders, and infectious illnesses. Located near San Francisco, we maintain an inclusive, team-oriented culture with a strong commitment to innovation and patient-focused solutions. Our funding exceeds $100 million from leading investors.