Executive Director, Pharmacovigilance

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit

We are seeking an Executive Director, Pharmacovigilance to serve as BBOT's internal pharmacovigilance lead and subject matter expert across its early-phase oncology pipeline. Reporting to the CMO/CDO, this individual will be the company's first dedicated PV hire-building and owning the pharmacovigilance function from the ground up, spanning both safety science and safety operations. The ED will be accountable for the end-to-end safety profile of BBOT's programs, overseeing all internal and outsourced PV activities, and serving as the primary interface with regulatory agencies, CROs, and cross-functional teams on matters of drug safety.

This is a high-impact, hands-on leadership role for a seasoned PV professional who is comfortable operating as an independent function head in a lean, fast-moving oncology biotech and who may grow a small team as the pipeline expands.

• Serve as BBOT's internal pharmacovigilance subject matter expert and safety medical lead, providing medical and scientific oversight of all safety data across the clinical portfolio
• Lead ongoing safety surveillance and signal detection activities across all programs; evaluate individual case safety reports (ICSRs), including SAEs and SUSARs, and provide real-time medical assessment throughout the development lifecycle
• Chair and facilitate Safety Review Team meetings; develop and maintain product-specific safety monitoring plans, risk management strategies, and benefit-risk frameworks for assigned programs
• Author and review safety-related content for regulatory submissions and documents, including INDs, IBs, DSURs, annual safety reports, , REMS, RMPs, and NDA/BLA safety sections
• Serve as BBOT's primary safety representative in interactions with FDA, EMA, and other global health authorities; prepare for and participate in safety-related regulatory meetings and respond to agency queries
• Collaborate with Clinical Development, Clinical Pharmacology, and Translational Medicine on protocol design, informed consent forms, safety stopping rules, dose escalation criteria, and interpretation of emerging safety signals

• Establish, maintain, and continuously improve BBOT's pharmacovigilance system, including adverse event collection, processing, and reporting workflows in compliance with global GVP, GCP, ICH E2A-E2F guidelines, and applicable FDA and EMA regulations
• Ensure timely and accurate reporting of ICSR reports, expedited reports, and aggregate safety reports in accordance with all applicable regulatory requirements and timelines
• Develop and maintain pharmacovigilance SOPs, work instructions, and training materials; lead safety-related inspection readiness activities and serve as the primary PV contact during audits and regulatory inspections
• Oversee the development, implementation, and maintenance of pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs) with CROs, partners, and co-development collaborators
• Establish and track pharmacovigilance quality and compliance metrics; proactively identify and remediate gaps in safety processes, systems, and documentation
• Support implementation and oversight of safety database systems (e.g., Argus, Veeva Vault Safety, or equivalent), whether managed internally or through a CRO/vendor

• Serve as BBOT's primary point of accountability for all outsourced pharmacovigilance activities; select, onboard, and oversee PV CROs and safety vendors across all programs, ensuring quality, compliance, and timely delivery of all PV deliverables
• Develop and manage PV vendor scopes of work, performance metrics, and governance frameworks; conduct regular oversight meetings and quality reviews of outsourced safety activities
• Partner with Clinical Operations, Regulatory Affairs, Data Management, and Biostatistics to ensure seamless integration of safety data collection, coding (MedDRA and WHO DD), and reporting into clinical study execution and data review processes
• Participate in cross-functional program teams as the safety lead, contributing to clinical development…