Associate Director or Director of Pharmacovigilance Operations

Compass Therapeutics, Inc. was founded in 2014 and is headquartered in Boston, MA. We are an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics to treat multiple diseases. Our robust pipeline currently includes four clinical assets spanning all phases of development, with novel mechanisms of action, and first-in-class or best-in-class potential across multiple tumor types. Our lead clinical-stage asset, tovecimig, has completed a randomized late-stage biliary tract cancer study and we are preparing for a BLA submission. We are now at an exciting inflection point as we build out a commercial organization to support our first product launch. This is a unique and pivotal moment to join us and help make a meaningful impact on patients’ lives. For more information, visit www.compasstherapeutics.com.

Our Clinical Development team is seeking a highly motivated Associate Director/Director of Pharmacovigilance (PV) Operations. The ideal candidate will have a proven track-record of PV operations, including experience supporting the transition from clinical to commercial stage, and will be a hands-on leader who thrives in a fast paced and collaborative environment.

This position reports to our VP of Drug Safety and Pharmacovigilance (DSPV) and is onsite 4 days/week in our office in Brighton, MA.

Responsibilities:

• Ensure Compass Pharmacovigilance (PV) objectives are achieved in alignment with timelines, quality standards, applicable regulations, and commercial readiness requirements
• Strategically lead the scale-up of Compass’ global PV operations infrastructure as the company transitions from a clinical-stage development pipeline to a commercial-stage company
• Manage scaling of PV operations, systems and processes, safety and vendor governance, risk management, internal and external partnerships, audit and inspection readiness, for commercial readiness in support of compliant regulatory filings and commercial launch; as detailed below
• Lead the design, implementation, and ongoing maintenance of the post-market PV system and associated Quality System to support upcoming marketing authorizations (NDA/MAA) and commercial readiness
• Support the VP of Pharmacovigilance in safety evaluation, benefit-risk assessment, and compliance activities by providing pharmacovigilance operations expertise
• Serve as the company’s pharmacovigilance operations expert, maintaining current knowledge of drug safety requirements and identifying risks, gaps, and opportunities for improvement
• Establish the PV operational governance framework, and optimize existing PV systems, processes, oversight of PV vendors, and infrastructure to support commercial readiness and scalable post-marketing commercial and medical strategies
• Serve as a core contributor to marketing authorization applications (NDA/MAA), co-authoring or reviewing clinical safety summaries, Risk Management Plans (RMPs), and Pharmacovigilance System Master File (PSMF), and other required safety documentation
• Author, enforce, and continuously improve internal PV policies, SOPs, charters, templates, forms, training materials, and meet global commercial Good Pharmacovigilance Practices (GVP)
• Draft and maintain Safety Data Exchange Agreements (SDEAs), safety product/project plans, quality processes, and related PV procedures, ensuring compliance by providing training
• Draft and negotiate SDEAs with global licensing partners and commercial distributors to establish clear responsibilities and timelines, to ensure safety data synchronization
• Optimize safety databases by directing the configuration, validation, and overseeing ongoing use of databases (e.g., Argus, ARISg) to accommodate commercial data volumes and requirements
• Oversee PV operational support for active Phase I–III clinical trials, including safety management plan (SMP) execution, SAE reconciliation, case processing, and coordination with internal and external service providers
• Lead the selection, qualification, contract negotiation, governance, and performance oversight of external PV vendors and CROs, including transition of vendor scopes from clinical-only to commercial case processing, escalating significant issues to the VP of Drug Safety/PV
• Establish and monitor rigorous metrics-based PV Key Performance Indicators (KPIs) to assess vendor performance, quality, regulatory compliance, timeliness, and data integrity ensuring high-quality case management, inspection readiness, and delivery of contracted services
• Collaborate with internal and external stakeholders to bridge clinical trial safety workflows with commercial case-management realities and manage scaling vendor networks
• Comply with PV regulatory timelines and meet corporate inspection readiness expectations
• Serve as the operational lead for pre-approval and post-approval regulatory inspections (FDA, EMA), coordinating preparation, responses, and follow-up activities for the PV function
• Oversee internal and external PV audits and investigations into late cases, deviations, or non-compliance, including implementation of robust Corrective and Preventive Action (CAPA) plans
• Partner cross-functionally with Clinical Development, Quality, Regulatory Affairs, Medical Affairs, Quality, and external vendors to integrate PV requirements and safety governance throughout drug development and corporate strategy
• Lead interactions with Safety Review Committees and provide input on IDMCs and other safety governance bodies

Qualifications:

• Bachelor’s degree in nursing (BSN), pharmacy, or a related healthcare/life science field required, Master’s degree in nursing (MSN) or an advanced degree preferred
• 8+ years of progressive clinical drug safety/pharmacovigilance experience in the biotech or pharmaceutical industry is required; small company experiences preferred
• Director-level candidates require 12+ years of experience, including positions of leadership
• Experience working within a company transitioning from clinical to commercial stage, or direct experience launching a new commercial pharmaceutical asset
• 3+ years of vendor oversight experience overseeing pharmacovigilance vendor performance
• Oncology experience preferred
• Deep expertise with and experience following regulations and guidelines for such as FDA, EMA, ICH, and global GVP regulations, including direct experience defending systems during regulatory agency inspections
• Expert-level knowledge working within global safety databases (Argus/ArisG) and clinical Electronic Data Capture (EDC) systems (Medidata Rave/InForm)
• Demonstrated proficiency working with and improving processes within a global Drug Safety Database required, as well as other relevant programs such as Microsoft Office Suite
• Expertise in pre- and post-approval PV/safety risk management process and procedures
• Thorough understanding of the drug development process and context applicable to safety surveillance activities, i.e. signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials
• Strong analytical ability to synthesize and analyze safety data effectively from various sources
• Proven experience working within a cross-functional team environment, ability to work in a fast-paced and collaborative environment, balancing multiple project objectives simultaneously
• Ability to assimilate clinical data and through comprehensive analysis/review and assessments
• Strong written, verbal, technical communication and presentation skills