Job Description Summary
Cambridge MA
Internal: Principal Scientist I or II
LI#-Hybrid
The Preclinical Safety (PCS) department within the Novartis Biomedical Research Translational Medicine Unit provides world class preclinical safety profiling and assessment for optimal drug discovery, development and commercialization, with state-of-the-art regulatory compliance.
As a Preclinical Safety Profiling (PSP) Expert, you will join our global PCS team to help us to unleash the power of early safety screening and profiling approaches for advancing translational safety assessment and to drive drug discovery and development. You will bring your curious, innovative, and collaborative mindset to leverage a wealth of non-clinical safety-related data generated within our department and deploy state-of-the-art laboratory science and data exploration methods to accelerate the advancement of innovative medicines.
Job Description
Key Responsibilities:- Design and execute the early safety screening & profiling strategies associated with secondary pharmacology and cardiovascular safety, in collaboration with internal and external stakeholders.
- Primary interface between PCS and our CRO partners.
- Manage internal relationships with PSP subject matter experts and the outsourcing resource group. Further develop data internalization processes and manage outsourcing budget.
- Effectively communicate with stakeholders, including experimental design, data quality, timeline requirements and flowchart planning.
- Understand and execute agreed business strategy defined by local and global Preclinical Safety Profiling requirements, ensuring appropriate coordination of projects.
- Participate in cross-functional early safety screening & profiling collaborations with Novartis Biomedical Research partners to support the early derisking of compounds, drug targets, and therapeutic modalities
- Deliver clear and concise presentations for audiences with different expertise
- In collaboration with cross-functional partners, provide scientific and strategic input to support the early derisking of compounds, drug targets, and therapeutic modalities
- Ensure quality and compliance of data generation, analyses and resultant reports
Essential Requirements
- Degree/Advanced Degree in Pharmacology, Toxicology or a Related Field
- 5+ years of relevant experience in pharmacology / toxicology
- Understands the basic concepts of hazard identification and risk assessment associated with drug ADME, off-target mitigation and cardiovascular safety.
- Familiar with early drug discovery processes
- Experience with data integrity and quality assurance practices.
- Articulates solutions / recommendations to business users. Presents analytical content concisely and effectively and influences the outcome of predictive safety profiling contributions.
- Collaborates with internal stakeholders, external partners, and cross-functional teams to solve critical business problems, propose operational efficiencies and innovative approaches.
- Familiar with visualization tools to increase efficiency and quality of data communication and interpretation.
Desired Requirements:
- Small molecule safety assessment experience
