VP – Development Operations

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

⚙️ Operations

👻 Ghost score 10%

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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

• Serve as a key member of the Development leadership team and contribute to portfolio-level strategy for BBOT’s clinical pipeline • Define and execute the operational strategy for the Development organization • Develop and maintain tools, licenses, and environments needed by Development functions in collaboration with IT • Establish a culture of operational excellence, efficiency, accountability, and continuous improvement • Identify organizational gaps and design practical, cost-effective solutions aligned with BBOT’s lean operating model • Represent Development Operations with senior leadership, the Board of Directors, and external partners • Provide strategic and operational oversight of clinical programs, ensuring timely, budget-compliant, and GCP/ICH-compliant execution • Lead clinical outsourcing strategy, including CRO and vendor selection, contracting, onboarding, and performance management • Develop and maintain a vendor governance framework • Partner with program managers and leads on trial timelines, site performance, enrollment strategy, risk mitigation, protocol development, study design, and resource planning • Oversee budget tracking, forecasting, and vendor invoice review with Finance • Oversee inspection readiness, eTMF completeness, and audit-ready standards • Oversee contractor and consultant engagement, onboarding, timesheet tracking, invoice payment, and offboarding • Partner with Finance, Legal, and HR on compliant, cost-effective contractor engagements • Monitor consultant utilization and performance and optimize external expertise • Own development, maintenance, training, and compliance of SOPs • Partner with Quality and Regulatory Affairs on ICH-GCP, FDA, and global regulatory compliance • Lead or oversee regulatory inspection and internal audit preparation • Serve as senior Development Operations contact during inspections • Implement KPIs, metrics, dashboards, and governance structures • Champion change management and adoption of operational best practices • Build, lead, and develop a high-performing Development Operations team • Oversee hiring and retention for assigned functions • Coach, mentor, and manage performance of direct reports and broader functional teams • Establish goals, development plans, and career pathways

🎯 Requirements

• Bachelor’s degree in life sciences, business, or a related field required • Advanced degree (M.S., M.B.A., or Ph.D.) preferred • Minimum 15 years of progressive experience in clinical development operations within the biopharmaceutical industry • At least 5 years in a senior leadership role overseeing one or more Development functions • Proven experience managing and developing high-performing teams, including direct leadership of functional managers and senior individual contributors • Deep expertise in clinical operations, clinical outsourcing, and CRO/vendor governance across global early- and late-phase oncology trials • Proven track record of developing, implementing, and maintaining SOPs and quality systems in a GCP-regulated environment • Strong understanding of ICH-GCP guidelines, FDA regulations, and global regulatory requirements governing clinical trials • Exceptional organizational, analytical, and interpersonal skills • Demonstrated ability to influence and drive alignment across functions and levels • Strong financial acumen, including experience with clinical trial budget management, vendor contracting, and forecasting • Oncology experience required; early-phase and late-phase oncology experience strongly preferred • Prior experience in a lean, startup, or high-growth biotech environment highly desirable • Ability to operate effectively with limited resources and high ambiguity • Excellent written and verbal communication skills • Ability to present complex operational topics clearly to the CMO/CDO, Board of Directors, and external partners • Proficiency in clinical trial systems such as CTMS, eTMF, and EDC • Proficiency in timeline management tools such as Smartsheet

🏖️ Benefits

• Full-time employment • Fully remote work • Opportunity to work at a clinical-stage biopharmaceutical company advancing novel small molecule therapeutics targeting RAS and PI3K malignancies • Leadership, mentorship, and career development opportunities • High-performance, inclusive, and mission-driven culture