Director, Nonclinical Safety Assessment Expert (Multiple Therapeutic Areas)

Job Description Summary

Internal Title: Director

#LI-Hybrid

Location: Cambridge, MA or San Diego, CA

In this key role you will provide global, end to end nonclinical safety leadership across multiple therapeutic areas and modalities, ensuring scientifically robust, fit for purpose, and regulatory compliant safety strategies that enable successful clinical trial initiation and support registration. You will serve as the primary Preclinical Safety (PCS) authority on cross functional R&D teams and in interactions with global Health Authorities.

You will be a critical enabler of portfolio progression, providing authoritative nonclinical safety leadership, regulatory credibility with Health Authorities, and strategic integration across therapeutic areas and modalities. Success is defined by timely clinical entry, robust regulatory outcomes, and strong cross functional trust in PCS scientific leadership.

 

Job Description

Key Responsibilities:
•    Lead PCS Target Teams to design, integrate, interpret, and apply nonclinical safety assessment programs, including impact on development strategy and timelines.
•    Represent Preclinical Safety on cross functional R&D project teams, ensuring scientifically sound and globally compliant nonclinical safety packages.
•    Define and implement fit for purpose, modality appropriate nonclinical programs in collaboration with PCS and external line functions.
•    Lead global Health Authority interactions, including negotiation on safety issues, scientific interpretation, and acceptability of nonclinical packages.
•    Author nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval (e.g., IND/NDA).
•    Drive and coordinate communication strategies between PCS and R&D project teams.
•    Participate in or lead internal and external cross functional initiatives advancing PCS and/or Translational Medicine objectives and current safety topics.
•    Support evaluation of in licensing and out licensing opportunities, including collaboration with BD&L and integration activities.
•    Mentor and coach colleagues on drug development strategy and project related scientific decision making.

Essential Requirements:
•    Advanced scientific degree (PhD, MD, DVM, PharmD, or equivalent) in Toxicology, Pharmacology, or related discipline; or DABT; or equivalent industry experience.
•    5 plus years experience as a nonclinical safety Project Team member, preferably across multiple development phases up to registration.
•    8 or more years experience in nonclinical drug development (e.g., project toxicologist, pharmacologist, study director).
•    Demonstrated expertise across multiple modalities (e.g., small molecules, biotherapeutics, oligonucleotides) and their safety considerations.
•    Proven track record of direct interaction with global Health Authorities, including shaping regulatory strategy and submission writing.
•    Recognized scientific and regulatory expertise in nonclinical safety assessment within a global drug development context.
•    Demonstrated leadership and influence in complex, matrix managed, international project environments.
•    Strong problem solving capability in multidisciplinary, project driven settings.

Desirable Experience:
•    Prior experience in the pharmaceutical industry.
•    Leadership or participation in relevant to drug development or safety assessment.

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