Overview

The Vice President, Pharmacovigilance & Risk Management will provide strategic and operational leadership for Celldex’s global pharmacovigilance and risk management function across the product lifecycle, from clinical development through commercialization.

 

Reporting to the SVP, Chief Medical Officer, this individual will serve as the company’s senior safety leader, responsible for the oversight, evolution, and execution of all pharmacovigilance activities, ensuring compliance with global regulatory requirements while proactively identifying, evaluating, and managing product safety risks.

 

This leader will play a critical role in shaping Celldex’s safety strategy in support of late-stage development, regulatory submissions, and launch preparation.

Responsibilities

Strategic Pharmacovigilance Leadership

• Provide overall strategic leadership and direction for the global Pharmacovigilance and Risk Management function
• Develop and execute the company’s global safety strategy across clinical and future commercial programs
• Lead the continued evolution of pharmacovigilance infrastructure, systems, processes, and governance to support organizational growth and commercialization readiness
• Serve as the senior safety advisor to executive leadership and cross-functional teams

Safety Surveillance & Risk Management

• Ensure oversight and execution of all safety surveillance activities, including:
• Individual case safety report (ICSR) processing and medical review
• Signal detection and management
• Aggregate safety analysis and reporting
• Benefit-risk assessments
• Risk management planning and mitigation strategies
• Oversee preparation and review of safety-related regulatory submissions and responses to global health authorities
• Ensure timely identification, evaluation, escalation, and communication of safety risks across programs

Regulatory & Compliance Oversight

• Maintain deep expertise in global pharmacovigilance regulations, guidance, and industry best practices
• Ensure compliance with FDA, EMA, ICH, and other applicable global safety reporting requirements
• Lead inspection readiness and support regulatory inspections and audits related to pharmacovigilance

Cross-Functional Leadership

• Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Quality, and Commercial organizations on safety-related strategy and execution
• Contribute to development programs, regulatory submissions, labeling discussions, and launch planning activities
• Support Safety Governance Committees and cross-functional safety review forums

Organizational & Operational Excellence

• Lead departmental operations including organizational design, resourcing, vendor oversight, SOPs, training, technology, and budget management
• Recruit, develop, and retain high-performing pharmacovigilance talent
• Foster a collaborative, patient-focused, and scientifically rigorous culture within the safety organization
• Drive operational excellence and continuous process improvement across the function

Qualifications

• 15+ years of experience within the pharmaceutical/biotechnology industry, including significant leadership experience in Pharmacovigilance and Drug Safety
• Deep expertise in global pharmacovigilance regulations, safety surveillance, and risk management across clinical development and post-marketing environments
• Experience supporting late-stage development programs, regulatory submissions, and/or product launches
• Proven ability to lead and scale pharmacovigilance organizations within a growing biotech or pharmaceutical company
• Strong scientific and clinical acumen with the ability to synthesize and communicate complex safety information
• Demonstrated success working cross-functionally and influencing within matrixed organizations
• Excellent leadership, communication, and stakeholder management skills
• Ability to thrive in a fast-paced, entrepreneurial environment

 

Preferred Skills:

• Experience in Immunology, Allergy, Dermatology, or related therapeutic areas preferred
• Experience supporting global development programs and commercialization readiness
• Experience with safety systems implementation and pharmacovigilance operational scaling in emerging biotech environments

 

Education:

• MD required, specialty and or experience managing drug safety