Job Type
Full-time
Description
Executive Director, Pharmacovigilance
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.
Requirements
Responsibilities
Safety Science and Medical Oversight
- 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
Safety Operations and Compliance
- 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 ICSRs, 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
Vendor Oversight and Cross-Functional Collaboration
- 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 plans, risk mitigation strategies, and go/no-go decision-making from a safety perspective
- Contribute to the development and oversight of Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) charters, processes, and outputs; prepare safety data packages and support safety narrative development for review committees
Function Building and Leadership
- Build and own BBOT's pharmacovigilance function from inception, establishing the infrastructure, systems, processes, and vendor relationships needed to support a growing early-phase oncology pipeline
- As BBOT's pipeline and headcount grow, recruit, develop, and lead thePV team, providing mentorship, direction, and performance management to internal safety staff and consultants
- Contribute to corporate strategic planning by providing pharmacovigilance insights on pipeline risk, regulatory strategy, and safety-related go/no-go criteria at the program and portfolio level
Requirements
Education and Qualifications
- M.D., D.O., or equivalent degree preferred; PharmD, Ph.D. or equivalent degree candidates with significant medical safety leadership experience will be considered
- Minimum 12 years of progressive experience in pharmacovigilance and/or drug safety within the biopharmaceutical industry, with at least 5 years in a senior leadership or function-head capacity
- Demonstrated expertise across both safety science (medical review, signal detection, benefit-risk assessment) and safety operations (ICSR processing, aggregate reporting, regulatory compliance, SOP development)
- Oncology experience required; early-phase oncology experience strongly preferred, including familiarity with oncology-specific adverse event profiles, dose escalation safety monitoring, and oncology-specific PV regulatory expectations
- Deep knowledge of global PV regulations and guidelines including FDA 21 CFR Parts 312 and 314, EMA GVP modules, ICH E2A-E2F, and MedDRA/WHO DD coding standards
- Proven experience establishing or significantly building out a pharmacovigilance function at a lean biotech or as an early PV hire; comfort operating as a solo function lead or with a small team and outsourced support model
- Extensive experience overseeing PV CROs and safety vendors, including vendor selection, governance, performance management, and quality oversight of outsourced safety activities
- Proven experience authoring and reviewing pharmacovigilance-related regulatory submissions, including DSURs, IB safety updates, IND annual reports, and NDA/BLA safety sections
- Experience interacting directly with FDA, EMA, and other health authorities on safety-related matters, including safety-focused meetings, queries, and commitments
- Familiarity with pharmacovigilance safety databases (e.g., Argus, Veeva Vault Safety, or ArisGlobal) and safety reporting systems; experience overseeing database management in a CRO-supported model
- Strong cross-functional leadership and communication skills; ability to distill complex safety data into clear, actionable insights for clinical teams, senior leadership, and health authorities
- Prior experience in a lean, startup, or high-growth biotech environment is highly desirable; demonstrated ability to build processes and infrastructure with limited resources in a fast-moving environment
Salary Description
263,000 - 325,000
