Novartis Group Companies
Associate Director, Nonclinical Safety Assessment Expert (Multiple Therapeutic Areas)
Cambridge (USA) · Director
Sponsorship not specifiedDetected 4 hours ago
Data AnalysisComplianceNegotiationClinical TrialsClinical ResearchPharmacologyPatient CareBioinformaticsResearchAnimal StudiesAnimal ModelsLeadershipCommunicationCollaborationProblem Solving
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About the role
- 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.
Responsibilities
- Lead PCS Target Teams to design, integrate, interpret, and apply nonclinical safety assessment programs, including impact on development strategy and timelines.
- Define and implement fit for purpose, modality appropriate nonclinical programs in collaboration with PCS and external line functions.
- 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.
- Support integration of in licensing and out licensing opportunities, including collaboration with BD&L and integration activities.
Requirements
- Advanced scientific degree (PhD, MD, DVM, PharmD, or equivalent) in Toxicology, Pharmacology, or related discipline
- Experience as a nonclinical safety Project Team member, preferably across multiple development phases up to registration.
- 5 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, oligonucleotides) and their safety considerations.
- Recognized scientific and regulatory expertise in nonclinical safety assessment within a global drug development context.
- Prior experience in the pharmaceutical industry.
Compensation
- $152,600.00 - $283,400.00
- The salary for this position is expected to range between $152,600 and $283,400 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.
Benefits
- Lead global Health Authority interactions, including negotiation on safety issues, scientific interpretation, and acceptability of nonclinical packages.
- Proven track record of direct interaction with global Health Authorities, including IND submission writing.
Equal opportunity
- The Novartis Group of Companies are Equal Opportunity Employers.
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