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 for drug candidates. The role leads cross-functional teams to develop integrated nonclinical toxicology study plans, draft regulatory responses and submission documentation, and manage 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 development timelines.
• Represents PCS on cross-functional R&D project teams to design compliant and scientifically relevant nonclinical safety packages.
• Identify fit-for-purpose nonclinical programs by modality and collaborate with line functions to achieve goals.
• 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, interpretation, and acceptability of nonclinical safety packages.
• Author nonclinical safety sections of internal and regulatory documents supporting development and approval.
• Evaluate in/out-licensing opportunities and perform due diligence as needed.
• Lead or participate in cross-functional groups on initiatives related to PCS objectives and nonclinical safety topics.
• Mentor colleagues on drug development strategy and project-related matters.

Qualifications

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

Skills

• Nonclinical safety strategy and planning
• Regulatory writing and submission preparation
• Cross-functional team leadership
• Global health authority communications
• Due diligence and licensing assessment

Education

• Relevant advanced degree in toxicology, pharmacology, or related field (implied by experience; explicit degree not listed in source)

Additional Requirements

• Travel expectations not specified in source; no additional physical requirements listed.