BBOT

Director

• Serve as BBOT’s internal pharmacovigilance subject matter expert and safety medical lead
• Provide medical and scientific oversight of safety data across the clinical portfolio
• Lead safety surveillance, signal detection, and medical assessment of ICSRs, SAEs, and SUSARs
• Chair Safety Review Team meetings and maintain safety monitoring plans, risk-management strategies, and benefit-risk frameworks
• Author and review safety content for INDs, IBs, DSURs, annual safety reports, REMS, RMPs, and NDA/BLA safety sections
• Represent BBOT in safety-related interactions with FDA, EMA, and other global health authorities
• Collaborate on protocol design, informed consent forms, safety stopping rules, dose escalation criteria, and emerging safety signals
• Establish and improve the pharmacovigilance system, including adverse-event collection, processing, and reporting workflows
• Ensure timely reporting of ICSRs, expedited reports, and aggregate safety reports
• Develop SOPs, work instructions, and training materials; lead inspection readiness and serve as PV contact during audits and inspections
• Oversee PVAs and SDEAs with CROs, partners, and collaborators
• Establish compliance metrics and remediate process, system, and documentation gaps
• Support safety database implementation and oversight
• Select, onboard, and oversee PV CROs and safety vendors
• Manage vendor scopes, performance metrics, governance frameworks, oversight meetings, and quality reviews
• Partner with Clinical Operations, Regulatory Affairs, Data Management, and Biostatistics on safety data integration, coding, and reporting
• Serve as safety lead on cross-functional program teams and contribute to development plans, risk mitigation, and safety go/no-go decisions
• Support DSMB/DMC charters, processes, outputs, safety data packages, and safety narratives
• Build BBOT’s pharmacovigilance function, infrastructure, systems, processes, and vendor relationships
• Recruit, develop, and lead the PV team as the pipeline grows
• Provide pharmacovigilance insights for corporate strategy, pipeline risk, regulatory strategy, and safety go/no-go criteria

Senior Director – Pharmacovigilance

Medical Director

• Own and continuously refine BBOT’s clinical outsourcing strategy
• Lead CRO and vendor selection for clinical programs, including RFPs, RFIs, vendor evaluations, and bid defense meetings
• Establish and maintain preferred provider relationships with pre-negotiated pricing frameworks
• Identify outsourcing needs early and ensure vendors are selected and onboarded ahead of program timelines
• Negotiate CRO and vendor contracts, work orders, change orders, master service agreements, and clinical budgets
• Manage the full contract lifecycle from scope development and proposal review through amendments, change orders, close-out, and financial reconciliation
• Evaluate vendor proposals and budgets against industry benchmarks and identify risks and pricing gaps
• Partner with Legal on compliant vendor agreements and coordinate PVAs, confidentiality agreements, and quality agreements
• Track contract timelines, expiry dates, and renewals
• Own monthly and quarterly financial reviews, accruals, purchase order management, and budget tracking
• Review and approve vendor invoices against contracts, work orders, and deliverables
• Maintain budget forecasts and report spend status, variances, and risks to program teams, Finance, and senior leadership
• Support clinical trial budget development with cost estimates, benchmarking data, and vendor inputs
• Lead or support final financial reconciliation for vendor engagements
• Establish vendor governance frameworks with KPIs, scorecards, escalation pathways, and performance reviews
• Serve as primary operational contact for CRO and vendor relationships
• Identify and resolve performance, quality, and timeline risks
• Ensure outsourced activities comply with GCP, regulations, and BBOT SOPs; support audit and inspection readiness
• Partner with Clinical Operations teams to integrate outsourced partners and drive accountability for deliverables and milestones

Senior Director – Pharmacovigilance

Associate Director – Clinical Outsourcing