Drug Inspector Jobs in Randolph, MA (NOW HIRING)

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 and hands-on VP of Pharmacovigilance. The ideal candidate will have a proven track-record of Pharmacovigilance leadership and risk management, and desires to be part of a fast paced and collaborative team.

This position reports to our Chief Medical Officer and is onsite 4 days/week in our office in Brighton, MA.

Responsibilities:

• Ensure Compass Clinical Department and Pharmacovigilance objectives are achieved in alignment with corporate milestones, quality standards and applicable regulations
• Provide strategic guidance on patient safety, benefit-risk assessment, safety evaluation, and compliance, to inform Compass' portfolio, Clinical Development, 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 to identify emerging risks, gaps, and opportunities
• Evaluate and optimize existing 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 our external vendors (e.g. CRO's) covering pharmacovigilance and medical risk management activities
• Lead cross-functional safety governance and partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Executive Leadership, and external vendors to integrate pharmacovigilance throughout drug development and corporate strategy
• 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 team and external service providers
• Ensure patient safety by monitoring patient safety profiles to identify and mitigate potential risks associated with Compass drugs; recommend updates to Development Core Safety Information (DCSI)/Reference Safety Information, communicate risks to applicable stakeholders
• Provide executive oversight and review of safety-related regulatory submissions, cross functionally collaborating with Clinical, Medical, Quality, and Regulatory, including DSURs, DCSI, Risk Management Plans, Investigator Brochures, Clinical Study Report, Informed Consent Forms (ICFs), protocols, reports, other required safety documentation in accordance with legal requirements, respective SOPs and Health Authority
• Review and clean clinical safety in an ongoing compliant manner
• Lead pharmacovigilance interactions with regulatory authorities, including responses to safety inquiries, inspections, audits, regulatory commitments, and submission of periodic reporting requirements for FDA, EMA, MHRA, and other applicable agencies
• Develop and maintain pharmacovigilance policies, SOPs, templates/forms, SDEAs, safety product/project plans, and quality processes, ensuring compliance by providing training to employees, CROs and investigational site personnel, etc.
• 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, pharmacovigilance 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

Qualifications:

• MD or an equivalent advanced degree required
• 10+ years of relevant clinical drug safety/pharmacovigilance experience in the biotech or pharmaceutical industry is required; small company experiences preferred
• Significant experience in broader pharmacovigilance/safety risk management in key leadership positions of responsibility within a pharmaceutical or biotech environment (industry, CRO)
• Oncology experience preferred
• Expertise in pre- and post-approval pharmacovigilance/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
• 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 work and mentor in a fast-paced and collaborative environment
• Comfortable with balancing multiple project objectives simultaneously
• Ability to assimilate clinical data and 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 required, as well as other relevant programs such as Microsoft Office Suite