VP of Drug Safety/Pharmacovigilance

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. This is a unique and pivotal moment to join us and help make a meaningful impact on patients’ lives.

About the role

This position reports to our Chief Medical Officer and is onsite 4 days/week in our Brighton, MA office. The VP of Pharmacovigilance will provide strategic leadership in patient safety, benefit-risk assessment, and compliance to inform our portfolio, clinical development, and corporate strategy.

Responsibilities

• Ensure Compass Clinical Department and Pharmacovigilance objectives align with corporate milestones, quality standards, and applicable regulations.
• Provide strategic guidance on patient safety, benefit-risk assessment, safety evaluation, and compliance to inform portfolio and corporate strategy.
• Serve as the company’s pharmacovigilance subject matter expert, leading patient safety initiatives and maintaining expertise in the evolving global drug safety landscape.
• Evaluate and optimize pharmacovigilance systems, processes, and infrastructure to support commercial readiness; develop post-marketing commercial/medical strategies.
• Establish and maintain the company’s pharmacovigilance governance framework, including cross-functional safety processes and oversight of external vendors (e.g., CROs).
• Lead cross-functional safety governance and partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Executive Leadership, and external vendors.
• Lead interactions with Safety Review Committees and provide input on IDMCs and other safety governance bodies.
• Provide medical oversight of signal detection, safety evaluation, benefit-risk assessment, and individual case safety review in collaboration with internal teams and external service providers.
• Monitor patient safety profiles to identify and mitigate potential risks; recommend updates to Development Core Safety Information (DCSI)/Reference Safety Information.
• Provide executive oversight and review of safety-related regulatory submissions, collaborating cross-functionally on DSURs, DCSI, Risk Management Plans, Investigator Brochures, Clinical Study Reports, Informed Consent Forms (ICFs), protocols, and other required documentation.
• Review and clean clinical safety data in an ongoing compliant manner.
• Lead pharmacovigilance interactions with regulatory authorities, including responses to safety inquiries, inspections, audits, and submission of periodic reporting requirements for FDA, EMA, MHRA, and other agencies.
• Develop and maintain pharmacovigilance policies, SOPs, templates/forms, SDEAs, safety product/project plans, and quality processes; ensure compliance through training for employees, CROs, and investigational site personnel.
• Manage pharmacovigilance vendor performance, ensuring high-quality case management, regulatory compliance, inspection readiness, and delivery of contracted services.
• Mitigate and escalate significant risks related to compliance, quality, budgets, timelines, or company milestones; oversee departmental budgets and vendor contracts.
• Build, mentor, and develop the pharmacovigilance function, fostering a culture of scientific excellence, accountability, and continuous improvement.

Requirements

• MD or equivalent advanced degree required.
• 10+ years of relevant clinical drug safety/pharmacovigilance experience in the biotech or pharmaceutical industry; small company experience preferred.
• Significant experience in broader pharmacovigilance/safety risk management in key leadership positions within a pharmaceutical or biotech environment (industry, CRO).
• Oncology experience preferred.
• Expertise in pre- and post-approval pharmacovigilance/safety risk management processes and procedures.
• Thorough understanding of the drug development process and safety surveillance activities, including signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials.
• Advanced working knowledge of and experience following FDA and ICH guidelines, including experience working on an IND or BLA.
• Knowledge of MedDRA terminology and its application.
• Proven experience working within a cross-functional team environment; ability to mentor in a fast-paced and collaborative setting.
• Comfortable balancing multiple project objectives simultaneously.
• Ability to assimilate clinical data through comprehensive analysis, review, and assessments.
• 3+ years of vendor oversight experience overseeing pharmacovigilance vendor performance.
• Strong written, verbal, technical communication, and presentation skills.
• Strong analytical ability to synthesize and analyze safety data effectively from various sources.
• Demonstrated proficiency working with and improving processes within a global Drug Safety Database and other relevant programs (e.g., Microsoft Office Suite).

Pay

Base Salary Range: $325,000 USD - $450,000 USD.

Benefits

• Comprehensive and market-leading compensation package, including base salary, discretionary bonus, and meaningful equity participation.
• Subsidized medical, dental, and vision premiums; health reimbursement arrangement; flexible spending accounts.
• Gym membership, employee assistance program, life insurance.
• 401(k) and Roth 401(k) programs with a 6% company match.
• Company parking and commuter reimbursement.
• Substantial vacation and leave policies, including summer Fridays and a winter shutdown week.
• Company-wide training, tuition and training reimbursement, recognition awards, and comprehensive performance management.
• Compass Culture Committee initiatives, including events, employee-driven programs, charitable causes, and values-aligned activities.