Director, Toxicology Immunology Therapeutic Area

Role Summary

The Director Toxicology Immunology Therapeutic Area provides nonclinical regulatory toxicology expertise on R&D project teams to support initiation of clinical trials and registration of drug candidates. Leads cross-functional teams to develop integrated nonclinical toxicology study plans, drafts regulatory responses, and manages submission documentation and project communications within PCS and Novartis.

Responsibilities

• Leads PCS Target Teams to design, integrate and interpret results of nonclinical safety assessment programs and assess impact on drug development and project timelines
• Represent PCS on cross-functional R&D project teams to design compliant and scientifically relevant nonclinical safety packages
• Identify fit-for-purpose and modality-specific nonclinical programs and collaborate with line functions outside of PCS
• Participate in internal initiatives to improve use of nonclinical/translational safety data for decision making
• Manage communications and build relationships between PCS and R&D project teams
• Negotiate with Global Health Authorities regarding safety issues and interpretation of nonclinical safety data
• Author nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval
• Evaluate in/out-licensing opportunities and perform technical due diligence as needed
• Participate or lead cross-functional groups on initiatives aligned with PCS objectives and nonclinical safety topics
• Mentor colleagues on drug development strategy and project-related matters

Qualifications

• Minimum 5 years experience as a nonclinical safety project team member with preclinical development experience in small molecules, biotherapeutics, or gene/cell therapies
• 8+ years experience in a nonclinical drug development scientific discipline (e.g., study director, project team toxicologist, pharmacologist)
• Experience communicating strategy and data to global health authorities to support clinical development and approval
• Knowledge of drug development strategy for immunomodulatory drugs
• Leadership in cross-industry organizations related to drug development
• Excellent interpersonal, leadership, organizational, and communication skills; ability to work independently under time constraints
• Ability to manage multiple projects and balance conflicting expectations in a matrix environment
• Customer-focused mindset and ability to represent PCS on cross-functional decision boards
• Strong problem-solving skills in a multi-disciplinary international environment
• Ability to mentor and coach

Skills

• Nonclinical safety assessment
• Regulatory strategy and submission preparation
• Cross-functional team leadership
• Technical due diligence
• Communication with health authorities

Education

• Not specified

Additional Requirements

• Location flexibility (US, UK, or Basel) as indicated