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Director – Development and Clinical Operations

Job not on LinkedIn

🔥 20 hours ago

🇺🇸 United States – Remote

💵 $206k - $277k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

Where this job comes from

Posted on BBOT's careers page, not through a job board

First seen by Remote Rocketship 20 hours ago

Still open on BBOT's site. Checked 3 hours ago.

Logo of BBOT

BBOT

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

• Provide program-level delivery oversight for assigned early-phase oncology studies • Ensure programs meet key milestones, timelines, and quality standards • Serve as a senior clinical operations resource for assigned programs • Support CRO, vendor, and site-level activities • Participate in cross-functional study team meetings and contribute to decision-making • Track key deliverables and timelines and escalate risks or issues • Support inspection readiness, TMF quality, and audit readiness activities • Review study documents, tracking tools, monitoring plans, and study manuals • Support GCP compliance and SOP adherence • Maintain budget trackers, purchase order logs, accrual schedules, and spend forecasts • Review and process vendor invoices and resolve discrepancies with Finance and Development Business Operations • Contribute operational cost inputs to clinical trial budget development • Track actuals against plan and flag variances to senior leadership • Maintain study-level financial tracking tools and support portfolio-level budget reporting • Identify and implement clinical operations process improvements • Develop and maintain operational tools, templates, reference documents, SOPs, work instructions, and process guides • Participate in cross-functional working groups and operational cadences • Contribute to onboarding new vendors, CROs, or team members

🎯 Requirements

• Bachelor’s degree in life sciences, business, or a related field • Minimum 10 years of experience in clinical operations, development operations, or a related function in a pharmaceutical or biotechnology setting • Direct hands-on experience managing clinical trial execution • Experience as a clinical operations lead or CTM on early-phase oncology trials • Ownership of study timelines, site management, vendor coordination, and TMF quality • Experience supporting clinical trial budget tracking, accruals, and financial review processes • Proficiency in Excel and operational tracking tools such as Smartsheet • Ability to develop or improve operational tools, templates, and process documentation in a cross-functional environment • Strong working knowledge of ICH-GCP, GCP compliance requirements, and clinical trial regulatory standards • Excellent organizational, communication, and problem-solving skills • Ability to manage multiple concurrent workstreams in a fast-paced, lean biotech environment • Proficiency in clinical trial systems such as EDC, CTMS, and eTMF • Proficiency in Microsoft Office Suite • Prior experience in a lean or startup biotech environment is highly desirable • Global trial experience is required

🏖️ Benefits

• Competitive salary • Benefits • Meaningful equity participation in a company entering the public market • Fully remote work

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