Director Toxicology - Immunology Therapeutic AreaSummary: The purpose of the role is to provide nonclinical regulatory toxicology expertise on RandD project teams supporting the successful initiation of clinical trials and achievement of registration for drug candidates of various modalities.

The Director level Project Team Member leads cross functional Associates (i.e., PCS Target Team) to develop and implement integrated nonclinical toxicology study plans, drafts regulatory responses and all required submission documentation, and manages the respective project communication strategy within PCS and Novartis.

About The RoleThis hybrid role can be based in Basel or London (White City).

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 RandD project teams to design appropriately compliant and scientifically relevant nonclinical safety package

Recognizes the need for a “fit for purpose and modality” nonclinical program as needed and collaborates 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 RandD project teams

Negotiates with Global Health Authorities worldwide regarding safety issues, scientific interpretation and acceptability of the 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)

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, planning and time management skills; strong oral and written communication and influencing abilities

Ability to work independently and efficiently under time constraints while managing multiple projects and conflicting expectations in a matrix environment

Customer-focused mindset and ability to represent PCS on Novartis cross-functional decision boards or other project teams

Recognized expertise in technical and scientific problem solving in a multi-disciplinary international environment

Ability to mentor and coach

Why Novartis?Our purpose is to reimagine medicine to improve and extend people’s lives. We aim to be the most valued and trusted medicines company in the world, driven by our people. Join us to contribute to this mission.

Diversity and InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network to stay connected and learn about suitable career opportunities: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

https://www.novartis.com/careers/benefits-rewards

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https://www.novartis.com/about/strategy/people-and-culture

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