Director, Toxicology Multiple Therapeutic Areas

Job Description Summary

Director, Toxicology Multiple Therapeutic Areas

#LI-Hybrid

This position will be located in the US (Cambridge, MA)

We are seeking a Director Toxicology that will provide nonclinical regulatory toxicology expertise on R&D 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. Preclinical Safety 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 Preclinical Safety (PCS) and Novartis

Job Description

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 :

The salary for this position is expected to range between $185,500 and $344,500 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here .

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$185,500.00 - $344,500.00

Skills Desired

Animal Models, Bioinformatics, Collaboration, Communication Skills, Data Analysis, Decision Making, Ethics, Laboratory, Leadership, Management, Mentorship, Problem Solving, Regulatory Compliance, Research, Risk Assessment, Toxicology, Training, Waterfall Model