Senior Clinical Trial Manager, Clinical Operations

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Iambic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🤖 Artificial Intelligence

💰 Series B on 2024-04

Biotechnology • Pharmaceuticals • Artificial Intelligence

Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

📋 Description

• Provide end-to-end operational leadership for complex clinical trials from start-up through close-out, ensuring delivery on time, within budget, and in compliance with global regulations and company SOPs • Lead cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners • Develop and execute enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and performance • Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support • Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution • Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials. • Lead study-related training for investigators, site personnel, and internal teams. • Proactively identify, assess, and escalate operational risks with mitigation strategies and clear recommendations. • Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities. • Travel up to 10% as required to support study oversight and site engagement

🎯 Requirements

• Bachelor’s degree in life sciences or related field with 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, and/or CRO environments • Demonstrated expertise managing clinical trials from start-up through close-out, with experience overseeing global, multi-site studies and CRO partners • Experience in oncology clinical trials required; solid tumor and early-phase (Phase I/Ib or II) experience preferred • In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory requirements, with a strong focus on quality and inspection readiness • Proficiency with clinical trial systems, including CTMS, eTMF platforms, IRT systems, EDC systems, and safety databases • Ability to thrive in a collaborative, fast-paced, growth-stage biotech environment with evolving priorities and high accountability.

🏖️ Benefits

• company paid healthcare • flexible spending accounts • voluntary life insurance • 401K matching • uncapped vacation