Associate Director – Clinical Operations

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $175k - $245k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Lead day-to-day clinical trial execution for assigned studies, including site activation, enrollment, monitoring, and closeout • Serve as primary clinical operations lead and main contact for CROs, vendors, and clinical sites • Lead cross-functional trial team meetings and drive alignment on deliverables, timelines, and risk mitigation • Provide direction and mentorship to Clinical Trial Managers • Manage CRO and vendor relationships, deliverables, performance metrics, and issue resolution • Drive vendor integration across CROs, central labs, and specialty service providers • Track and forecast study budgets; report variances and review vendor invoices • Ensure completeness and inspection-readiness of the TMF/eTMF • Develop and maintain study manuals, ICFs, tracking tools, and monitoring plans • Monitor regulatory and GCP compliance; lead audit and inspection readiness preparation • Review clinical trial data listings and coordinate data review to resolve deviations, trends, discrepancies, and queries • Oversee lab sample tracking, shipment, reconciliation, and vendor coordination • Coordinate availability of clinical and non-clinical trial supplies • Lead SOP development and implementation and contribute to process improvement • Maintain relationships with investigators and trial site managers • Represent clinical operations in cross-functional meetings and governance discussions • Contribute to feasibility assessments and protocol development

🎯 Requirements

• Bachelor’s degree in life sciences or related field • Minimum 8–10 years of experience in Clinical Operations, managing clinical trials within the biopharma industry, including global trial experience • Ability to independently lead clinical trials from start-up through close-out, including financial tracking, reporting, and vendor management • Experience providing direction or informal management to CTMs or equivalent clinical operations staff; formal people management experience a plus • Strong understanding of CRO/vendor oversight and clinical development processes • Experience managing complex, multi-vendor programs • Experience with cross-functional leadership and clinical teams, including data review and study reporting activities • Early-phase oncology experience preferred • Prior experience in a lean or startup environment highly desirable • Experience maintaining a submission-ready eTMF required • Experience in Quality Assurance, SOP and study plan writing, and audit/inspection readiness • Strong knowledge of ICH-GCP and global regulatory requirements • Proficiency in clinical trial systems (e.g., EDC, CTMS, eTMF), timeline management tools (e.g., Smartsheet), and Microsoft Office Suite • Excellent project management, communication, and problem-solving skills; ability to lead and influence in a cross-functional environment

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