Key Responsibilities:

• Leads PCS Target Teams  to design, integrate and interpret results of nonclinical safety assessment program including impact to drug development and/or project timeline
• Represents PCS on cross functional R&D project teams to design appropriately compliant and scientifically relevant nonclinical safety package
• Recognize the need for a “fit for purpose and modality” nonclinical program as needed and collaborate with line functions outside of PCS to accomplish this goal
• Participates in internal Novartis initiatives to improve use of nonclinical/translational safety data for drug development decisions.
• Manages communications and builds relationships between PCS and R&D project teams
• Negotiates with Global Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability nonclinical safety package to support clinical trials and market approval.
• Responsible for authoring nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval
• May evaluate in/out-licensing opportunities and carries out technical Due Diligence activities upon request.
• Participates or Leads internal and/or external cross-functional groups on key initiatives focused on PCS objectives and/or current nonclinical safety topics.
• Mentors colleagues on drug development strategy and project-related matters

Essential Requirements:

• Minimum of 5 years experience as a nonclinical safety Project Team member; Demonstrated experience in the preclinical development of small molecule, biotherapeutics and/or gene and cell therapies and the safety issue awareness of these modalities.
• 8+ years experience in a nonclinical drug development scientific discipline (e.g. study director, project team toxicologist or pharmacologist).

• Demonstrated experience in direct or written communication of strategy and data to global health authorities, supporting clinical development and market approval.
• Knowledge of drug development strategy for immunomodulatory drugs
• Leadership in cross-industry organizations (discipline-related or related to drug development).
• Excellent interpersonal, leadership, organizational skills (e.g. planning and time management) and teamwork skills. Excellent oral and written communication and influencing skills. Highly efficient, self-motivated, flexible and able to work independently and efficiently under time constraints.
• Ability to focus and work on several projects simultaneously and to effectively manage conflicting expectations from the line unit, TA Strategy team and project teams in a matrix management environment.
• Customer focused thinking. Recognized ability to represent PCS on Novartis cross functional decision boards or other cross functional project teams.
• Recognized expertise in technical and scientific problem solving in a project driven, multi-disciplinary international environment.
• Ability to mentor and coach