Job Type
Full-time
Description
We are seeking a
Vice President, Development Operations to serve as a key operational and strategic leader within BBOT's Development organization. Reporting to the CMO/CDO, the VP will have functional ownership of Clinical Operations and Outsourcing, the oversight of contractors and consultants across the Development organization, and oversight of other functions/resources as assigned. This Leader will build and enforce a culture of operational excellence, compliance, and continuous improvement-ensuring that BBOT's development operations infrastructure scales effectively as its oncology pipeline advances. The ideal candidate brings deep Clinical Development and Clinical Operations expertise in the oncology space, proven people leadership capabilities, and a track record of building best-in-class teams at a lean, high-growth biotech.
Requirements
ResponsibilitiesStrategic Leadership and Organizational Development - Serve as a key member of the Development leadership team, reporting to the CMO/CDO and contributing to portfolio-level strategy for BBOT's clinical pipeline
- Define and execute the operational strategy for the Development organization, ensuring that systems, processes, and infrastructure are fit-for-purpose and scalable for future growth; collaborate with IT to develop and maintain tools, licenses, and environments needed by Development functions
- Establish and foster a culture of operational excellence, efficiency, accountability, and continuous improvement across all functions under the VP's remit
- Proactively identify organizational gaps and design practical, cost-effective solutions that align with BBOT's lean operating model and stage of development
- Represent Development Operations in engagements with senior leadership, the Board of Directors, and external partners, as appropriate
Clinical Operations and Outsourcing Oversight - Provide strategic and operational oversight of BBOT's clinical programs, ensuring high-quality execution across all studies on time, within budget, and in compliance with GCP/ICH guidelines and applicable regulatory requirements
- Lead BBOT's clinical outsourcing strategy, overseeing the selection, contracting, onboarding, and performance management of CROs, central labs, and other clinical vendors; develop and maintain a vendor governance framework that ensures transparency, accountability, and fiscal responsibility across all external partnerships
- Partner with program managers and program leads to drive cross-functional alignment on trial timelines, site performance, enrollment strategy, and risk mitigation; provide operational input into protocol development, study design, and resource planning
- Oversee budget tracking, forecasting, and vendor invoice review for outsourced activities in partnership with Finance; identify emerging outsourcing models to optimize BBOT's approach to clinical execution as the portfolio expands
- Oversee inspection readiness and quality across all active clinical programs, ensuring eTMF completeness and audit-ready standards are maintained at all times
Contractor and Consultant Oversight- Provide day to day oversight of the engagement, onboarding, timesheet tracking, invoice payment, and offboarding of contractors and consultants across the Development organization, with input from functional SME's overseeing contractor and consultant work as needed
- Partner with Finance, Legal, and HR to ensure contractor engagements are compliant, cost-effective, and appropriately scoped and budgeted
- Maintain visibility into consultant utilization and performance across Development functions, identifying gaps and optimizing the use of external expertise
SOPs, Compliance, and Process Excellence - Accountable for development, maintenance, training, and compliance of SOPs across Development functions, in partnership with functional leads and SME's
- Partner with Quality and Regulatory Affairs to ensure all Development Operations activities are conducted in accordance with ICH-GCP guidelines, FDA regulations, and applicable global regulatory requirements
- Lead or oversee preparation for regulatory inspections and internal audits; serve as the senior Development Operations contact during inspections
- Implement KPIs/metrics, dashboards, and governance structures to monitor operational performance, compliance, and efficiency across Development functions
- Champion change management initiatives that improve operational processes and drive adoption of best practices across the Development organization
People Leadership and Mentorship - Build, lead, and develop a high-performing Development Operations team; oversee activities related to hiring and retention among assigned functions
- Provide ongoing coaching, mentorship, and performance management to direct reports and broader functional teams, fostering a culture of growth, accountability, and collaboration
- Establish clear goals, development plans, and career pathways for team members at all levels
- Serve as a role model for BBOT's values, promoting a high-performance, inclusive, and mission-driven culture across the Development organization
RequirementsEducation and Qualifications - 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, with 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 the conduct of 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 is highly desirable; ability to operate effectively with limited resources and high ambiguity
- Excellent written and verbal communication skills, with the ability to present complex operational topics clearly to the CMO/CDO, Board of Directors, and external partners
- Proficient in clinical trial systems (e.g., CTMS, eTMF, EDC) and timeline management tools (e.g., Smartsheet)
