15h Left: Director - Toxicology Immunology Therapeutic Area...

Job Description Summary

#LI-Hybrid

About the role:

This position can be located in Westworks, London, UK or US (Cambridge, MA or East Hanover, NJ).

The Director of Toxicology and Immunology in the Therapeutic Area will provide nonclinical regulatory toxicology expertise to R&D project teams, supporting the initiation of clinical trials and registration of drug candidates across modalities. The Director leads cross-functional teams (e.g., PCS Target Team) to develop and implement integrated nonclinical toxicology study plans, draft regulatory responses, prepare submission documentation, and manage project communication strategies within PCS and Novartis.

Key Responsibilities:

• Lead PCS Target Teams to design, integrate, and interpret nonclinical safety assessment programs, considering their impact on drug development and project timelines.
  
• Represent PCS on cross-functional R&D project teams to ensure appropriately compliant and scientifically relevant nonclinical safety packages.
  
• Identify the need for modality-specific nonclinical programs and collaborate across functions to develop these programs.
  
• Participate in initiatives to enhance the use of nonclinical/translational safety data for drug development decisions.
  
• Manage communication and build relationships between PCS and R&D project teams.
  
• Negotiate with global health authorities regarding safety issues, scientific interpretations, and acceptability of nonclinical safety packages for clinical trials and market approval.
  
• Author nonclinical safety sections of internal and regulatory documents supporting clinical development and approval.
  
• Evaluate licensing opportunities and conduct technical due diligence as needed.
  
• Lead or participate in cross-functional groups on key initiatives related to PCS objectives and nonclinical safety topics.
  
• Mentor colleagues on drug development strategies and project-related matters.
  
  Essential Requirements:
  
  
• Minimum of 5 years experience as a nonclinical safety project team member, with demonstrated experience in preclinical development of small molecules, biotherapeutics, or gene and cell therapies.
  
• 8+ years experience in a nonclinical drug development discipline (e.g., study director, toxicologist, pharmacologist).
  
• Proven experience communicating strategies and data to global health authorities supporting clinical development and approval.
  
• Knowledge of drug development strategies for immunomodulatory drugs.
  
• Leadership experience 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 conflicting expectations in a matrix environment.
  
• Customer-focused mindset and ability to represent PCS on decision boards and project teams.
  
• Expertise in scientific problem solving in a multidisciplinary, international setting.
  
• Ability to mentor and coach colleagues.
  
  Skills Desired
  #J-18808-Ljbffr