Associate Director or Director of Pharmacovigilance Operations

Compass Therapeutics, Inc. is an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics. Our robust pipeline 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 building out a commercial organization to support our first product launch.

About the role

The Associate Director/Director of Pharmacovigilance (PV) Operations will be a hands-on leader ensuring Compass Pharmacovigilance objectives are achieved in alignment with timelines, quality standards, and commercial readiness requirements. This position reports to the VP of Drug Safety and Pharmacovigilance and is onsite 4 days/week in Brighton, MA.

Responsibilities

• Strategically lead the scale-up of Compass’ global PV operations infrastructure as the company transitions from clinical-stage to commercial-stage.
• Manage scaling of PV operations, systems, processes, safety and vendor governance, risk management, internal and external partnerships, audit and inspection readiness for commercial readiness.
• Lead the design, implementation, and 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 PV operations expertise.
• Serve as the company’s PV 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.
• 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).
• 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 for 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 transitioning vendor scopes from clinical-only to commercial case processing.
• Establish and monitor rigorous metrics-based PV Key Performance Indicators (KPIs) to assess vendor performance, quality, regulatory compliance, timeliness, and data integrity.
• Collaborate with internal and external stakeholders to bridge clinical trial safety workflows with commercial case-management realities and manage scaling vendor networks.
• 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, 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.

Requirements

• 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; small company experience 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 regulations and guidelines 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 and other relevant programs such as Microsoft Office Suite.
• Expertise in pre- and post-approval PV/safety risk management processes and procedures.
• Thorough understanding of the drug development process and context applicable to safety surveillance activities, including 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, balancing multiple project objectives simultaneously.
• Strong written, verbal, technical communication, and presentation skills.

Benefits

• Comprehensive and market-leading compensation and benefits package, including base salary, discretionary bonus, and meaningful equity participation.
• Subsidized medical, dental, and vision premiums, along with a health reimbursement arrangement and flexible spending accounts.
• Gym membership, employee assistance program, life insurance, and more.
• 401(k) and Roth 401(k) programs with a 6% company match.
• Company parking, commuter reimbursement, and substantial vacation and leave policies, including summer Fridays and a winter shutdown week.
• Investment in growth and development through company-wide training, tuition and training reimbursement, recognition awards, and comprehensive performance management.
• Compass Culture Committee initiatives, including events that build camaraderie, celebrate wins, and support charitable causes.

Pay

Base salary range: $175,000 USD - $250,000 USD.

Schedule

Onsite 4 days/week in Brighton, MA.