Director, Preclinical Safety Neuroscience Therapeutic Area

Job Description Summary

#LIHybrid

This position will be located in the US (East Hanover NJ Cambridge MA or San Diego CA) and will not have the ability to be remote.

The purpose of the role is to 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 PTM leads cross functional associates (i.e. Preclinical Safety (PCS) target team) to develop integrated nonclinical toxicology study plans drafts regulatory responses and all required submission documentation and manages the respective project communication strategy within PCS.

Job Description

Key Responsibilities:

Leads PCS Target Teams to 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
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.
Evaluates in/outlicensing opportunities and carries out technical Due Diligence activities in collaboration with BD&L.
Participates or leads internal crossfunctional groups on key initiatives focused on Translational Medicine or PCS objectives and/or current nonclinical safety topics.
Mentors colleagues on drug development strategy and projectrelated matters
Responsible for authoring nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval.

Essential Requirements:

• PhD in Pharmacology Toxicology or a related biological science or an MD/DVM/ PharmD or equivalent with a strong background or equivalent work experience

• Minimum of 5 years experience as a nonclinical safety Project Team member preferably including experience in all development phases.

• Demonstrated experience in communication of strategy and data to global health authorities (such as IND/NDA submission documentation writing) supporting clinical development and market approval.

• Recognized globally for scientific and regulatory expertise in drug development and safety assessment.

• Recognized for leadership potential and ability to represent PCS on Novartis cross functional decision boards or other cross functional project teams.

• Recognized expertise in problem solving in a project driven multidisciplinary international environment.

Desirable Requirements:

• Demonstrated knowledge of drug development strategy for neurodegenerative diseases

• Prior experience working in pharmaceutical industry

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $185500 to $344500/annually however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

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 email to or call 1(877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$185500.00 $344500.00

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