Senior Director, Clinical Operations

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.

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.

, 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.

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.

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.