Associate Director, Nonclinical Safety Assessment Expert 0ncology
Novartis
September 03, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
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 BD&L collaboration 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+ years as a nonclinical safety Project Team member, preferably across multiple development phases up to registration.
- 8+ years of nonclinical drug development experience (e.g., project toxicologist, pharmacologist, study director).
- Expertise across multiple modalities (small molecules, biotherapeutics, radioligand therapies) and safety considerations.
- Proven experience interacting with global Health Authorities, including IND submission writing.
- Recognized scientific/regulatory expertise in nonclinical safety assessment in a global drug development context.
- Leadership in complex, matrix-managed, international projects.
- Strong multidisciplinary problem-solving.
Desirable Experience
- Prior pharmaceutical industry experience.
- Participation in external consortia/committees relevant to drug development or safety assessment.
Benefits (as stated)
- Salary range: $152,600.00–$283,400.00 USD annual; performance-based cash incentive; possible eligibility for annual equity awards.
- US comprehensive benefits: health, life, disability, 401(k) with match, and time-off package.
Application Instructions
- Send requests for reasonable accommodations to [email protected] or call +1(877)395-2339, including the job requisition number.
- 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 BD&L collaboration 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+ years as a nonclinical safety Project Team member, preferably across multiple development phases up to registration.
- 8+ years of nonclinical drug development experience (e.g., project toxicologist, pharmacologist, study director).
- Expertise across multiple modalities (small molecules, biotherapeutics, radioligand therapies) and safety considerations.
- Proven experience interacting with global Health Authorities, including IND submission writing.
- Recognized scientific/regulatory expertise in nonclinical safety assessment in a global drug development context.
- Leadership in complex, matrix-managed, international projects.
- Strong multidisciplinary problem-solving.
Desirable Experience
- Prior pharmaceutical industry experience.
- Participation in external consortia/committees relevant to drug development or safety assessment.
Benefits (as stated)
- Salary range: $152,600.00–$283,400.00 USD annual; performance-based cash incentive; possible eligibility for annual equity awards.
- US comprehensive benefits: health, life, disability, 401(k) with match, and time-off package.
Application Instructions
- Send requests for reasonable accommodations to [email protected] or call +1(877)395-2339, including the job requisition number.