Senior Director, Safety & Pharmacovigilance

CytomX Therapeutics, Inc.•Emeryville, CA

6d•$285,000 - $350,000•Hybrid

About The Position

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. 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 Chief Medical Officer, 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.

Requirements

MD in a relevant health or life-sciences discipline.
8-10 years of progressively responsible pharmaceutical or biotechnology drug-safety, pharmacovigilance, or clinical-development experience with at least 4 years of leadership experience.

Nice To Haves

Demonstrated experience leading safety strategy and benefit-risk assessment for clinical-stage development programs.
Proven experience with and knowledge of clinical research and global regulatory requirements with a focus on safety reporting (e.g., IND, BLA filings, etc.), practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities.
Well versed in clinical aspects of FDA and other global regulatory guidance and regulations
A solid grasp of safety and pharmacovigilance principles with respect to early and late-stage clinical trials, data analysis and interpretation is required.
Experience with safety databases (i.e., Argus, Aris) and safety coding dictionaries (i.e., MedDRA, WHODRUG)
Experience developing or reviewing clinical and regulatory safety documents and communicating safety conclusions to cross-functional teams and senior leadership.
Demonstrated ability to lead complex initiatives, influence without formal authority, and make sound decisions in situations involving incomplete information or limited precedent.
Well-developed presentation, communication, and interpersonal skills, including strong oral and written communication skills.
Experience supporting oncology clinical development. Experience supporting clinical development or pharmacovigilance activities in gastrointestinal (GI) indications a plus.
Experience with one or more therapeutic modalities relevant to CytomX’s publicly described pipeline, including antibody-drug conjugates or immune modulators.
Experience interacting with regulatory authorities or supporting marketing-application and health-authority submission activities.
Experience overseeing external pharmacovigilance service providers, development partners, or safety-data exchange relationships.
Experience supporting pharmacovigilance inspections, audits, quality investigations, or corrective and preventive action plans.
Experience working effectively in a small or mid-sized biotechnology environment with evolving programs and priorities.

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 developments relevant to CytomX programs.
Communicate complex safety information clearly and appropriately to senior leaders, regulatory authorities, investigators, partners, and other internal and external stakeholders.
Provide functional expertise, coaching, and guidance to colleagues without direct people-management responsibility.