Senior Director, Clinical Operations
San Mateo, CAFull-time$275–295K/yrPosted 2mo agoStill listed 3 days ago
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Job overview
BigHat Biosciences is hiring a Senior Director, Clinical Operations. The Senior Director, Clinical Operations will lead the design, execution, and management of early‑stage oncology and inflammatory disease biologic trials, aligning strategies with corporate goals and regulatory standards while building a high‑performing operations team in a fast‑paced startup environment.
Key focus areas include Develop and execute clinical operational strategies to advance biologics from early‑phase trials to regulatory approval, Collaborate with cross‑functional teams to align clinical strategies with company goals, and Provide insights into trial design, site selection, and patient recruitment strategies.
Successful candidates bring Experienced Clinical Operations Lead and Early-Stage Clinical Development Of Biologic Drugs. Important skills include Oncology, Inflammatory Diseases, ICH-GCP Guidelines, FDA Regulations, EMA Regulations, and Global Clinical Trial Processes. Preferred (not required): Molecularly Targeted Therapies.
Skills & qualifications
Skills
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Full job description
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.
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