Job ID REQ-10050493
May 11, 2025
USA
#LI-Hybrid
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.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/out-licensing opportunities and carries out technical Due Diligence activities in collaboration with BD&L.
Participates or leads internal cross-functional groups on key initiatives focused on Translational Medicine or PCS objectives and/or current nonclinical safety topics.
Mentors colleagues on drug development strategy and project-related matters
Responsible for authoring nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $185,500 to $344,500/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 sign-on 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 at-will 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.
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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 & 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.
Division Biomedical Research
Business Unit Pharma Research
Location USA
State Massachusetts
Site Cambridge (USA)
Company / Legal Entity U175 (FCRS = US175) Novartis Institutes for BioMedical Research, Inc.
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