Director, Nonclinical Safety Assessment Expert (Multiple Therapeutic Areas)

Novartis • Cambridge, MA

3d • Hybrid

About The Position

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.

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.

Nice To Haves

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

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees