Senior Director, Safety & Pharmacovigilance at CytomX Therapeutics in Emeryville, CA

Job description

Headquarters Location: Emeryville, CA Candidate Location: Hybrid Travel Required: 15% Reports To: Vice President, Clinical Development Department: Pharmacovigilance Position Type: Full-time, Exempt About CytomX Therapeutics: CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel PROBODY® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-2051 and CX-801. Learn more at www.cytomX.com . Who You Are and What You’ll Do: You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will provide strategic and operational leadership for safety and pharmacovigilance activities across CytomX clinical development programs. Reporting to the Vice President, Clinical Development, you will serve as a senior safety subject-matter expert, leading cross-functional benefit-risk evaluation, safety surveillance, regulatory safety deliverables, and risk-management activities. In the near term, you will be responsible for building out safety and pharmacovigilance capabilities to support global late-stage development of varsetatug masetecan including potential regulatory approval. Job Responsibilities: Develop and lead pharmacovigilance and clinical safety strategies for assigned development programs, ensuring emerging safety information is evaluated and communicated appropriately. Lead ongoing safety surveillance, including review and interpretation of adverse-event data, laboratory findings, relevant medical literature, and other available safety information. Direct signal detection, validation, assessment, documentation, escalation, and risk-mitigation activities in collaboration with clinical, regulatory, statistical, and medical colleagues. Lead the safety content and review of clinical protocols, investigator brochures, informed-consent documents, regulatory submissions (eg, Periodic Benefit Risk Evaluation reports, Periodic Adverse Drug Experience Reports, Development Safety Update Reports, Integrated Summary of Safety) safety-management plans, and applicable aggregate safety reports. Provide clear, evidence-based benefit-risk assessments and recommendations to the Chief Medical Officer, program teams, and relevant governance bodies. Represent Safety and Pharmacovigilance on cross-functional development teams and provide strategic input into clinical-development plans, study designs, dose-selection discussions, and program decisions. Establish and facilitate appropriate safety-governance forums and ensure material safety issues are escalated promptly and documented clearly. Partner with Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Medical Affairs, Quality, and external experts to support consistent and timely safety decision-making. Oversee pharmacovigilance vendors and partners, including review of deliverables, performance, compliance, safety-data exchange, and issue resolution. Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents, and other tools pertaining to safety. Support inspection readiness and contribute to pharmacovigilance procedures, training, quality activities, corrective and preventive actions, and continuous process improvement. Maintain current knowledge of evolving global pharmacovigilance requirements, guidelines and scientific