Associate Director, Nonclinical Safety Assessment Expert 0ncology

Biopharma Careers; Cambridge (MA); On-site; USD 153,000 - 283,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Generous time-off

Job summary

Novartis is seeking a leader for global preclinical safety to guide nonclinical safety programs across multiple modalities. You will influence development strategy, interact with Health Authorities, and ensure robust, regulatory-compliant safety packages for clinical trial initiation and registration.

The role requires coordinating with cross-functional teams, leading safety strategies, and supporting licensing and translational medicine objectives.

Qualifications

• Advanced scientific degree in Toxicology, Pharmacology, or related discipline; or DABT; or equivalent industry experience.
• 5+ years as a nonclinical safety Project Team member across development phases to registration.
• 8+ years in nonclinical drug development across modalities and safety considerations.

Responsibilities

• Lead PCS Target Teams to design, integrate, interpret, and apply nonclinical safety programs.
• Represent Preclinical Safety on cross-functional R&D project teams for globally compliant safety packages.
• Define and implement modality-appropriate nonclinical programs in collaboration with PCS and external lines.
• Lead global Health Authority interactions, including safety issue negotiation and IND/NDA considerations.
• Author nonclinical safety sections of regulatory documents supporting clinical development and market approval.

Skills

Leadership

Regulatory experience

Cross-functional collaboration

Global Health Authority interactions

Education

PhD in Toxicology/Pharmacology or related

MD/DO/DVM/PharmD or DABT

Job description

In this key role you will provide global, end to end nonclinical safety leadership across multiple modalities in the Oncology therapeutic area, 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.

Relocation support is not provided so please only apply if this role is accessible for you.

This hybrid role is based in Cambridge, Mass with the expectation of being onsite 12 days per month.

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 internal and external cross functional initiatives advancing PCS and/or Translational Medicine objectives and current safety topics.
• Support integration of in licensing and out licensing opportunities, including collaboration with BD&L and integration activities.

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 of experience as a nonclinical safety Project Team member, preferably across multiple development phases up to registration.
• 8 or more years of experience in nonclinical drug development (e.g., project toxicologist, pharmacologist, study director).
• Demonstrated expertise across multiple modalities (e.g., small molecules, biotherapeutics, radioligand therapies) and their safety considerations.
• Proven track record of direct interaction with global Health Authorities, including IND 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
• Participation in external consortia/committees relevant to drug development or safety assessment.

Compensation and Benefits

• The salary for this position is expected to range from $152,600.00 - 218,000.00 - 283,400.00 USD Annual USD per year.The final salary offered is determined based on factors including 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.
• Compensation includes a performance-based cash incentive and, depending on the role level, eligibility for consideration for annual equity awards.
• Eligible United States-based employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and a generous time-off package.
• Learn more about life at Novartis, including our culture, rewards and benefits: Novartis Life Handbook