Safety Assessment Expert, Preclinical Safety

234846BR
Safety Assessment Expert, Preclinical Safety
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. Pre-Clinical Safety (PCS) provides world class preclinical safety profiling and assessment for optimal drug discovery, development and commercialization, with state-of-the-art regulatory compliance.

In this role the Safety Assessment Expert will be part of the Preclinical Safety (PCS) supporting multiple therapeutic areas including Cardiovascular and Metabolic Disease, Ophthalmology, Respiratory, Neuroscience, Oncology and Ophthalmology located at the Novartis Institutes for Biomedical Research (NIBR) site in Cambridge, MA. The Safety Assessment Expert will represent PCS on all project teams covering Drug Discovery, Early Clinical Assessment and Full Development in Cardiovascular and Metabolic Disease and assure appropriate design and execution of nonclinical safety assessment plans to meet team objectives and that the PCS support to all assigned projects is optimal in quality, timing and cost. The candidate will assemble and lead Target teams to ensure appropriate PCS input to project plans and appropriate resource planning within PCS; successful initiation of clinical trials and achievement of registration for drug candidates; integrated, scientifically relevant and appropriately compliant nonclinical safety assessment plans to support development/registration of drugs of various modalities, and preparation of regulatory submission documents. Timely communication to PCS and project teams regarding the theoretical or observed safety effects, their impact and proposed plans to address them, and resource requirements to execute nonclinical safety assessment plan, and clear, concise and correct communication of nonclinical safety results and their impact to Health Authorities and investigators are key components of this position. The Safety Assessment Expert will work closely with the PCS Therapeutic Area Head for alignment with PCS Therapeutic Area Strategy Teams, PCS line functions and NIBR/Novartis Development project/program teams in managing the preparation and presentation of nonclinical safety data in internal and external documents (e.g. Investigator’s Brochure, IND, CTD, IMPD, Health Authority briefing books) and in negotiation with Health Authorities. Evaluation of in-licensing opportunities and due diligence upon request.
The candidate will possess a PhD in pharmacology, toxicology or a related biological science or an MD/DVM/PharmD or equivalent with a strong biological background or equivalent work experience. Demonstrated experience in the preclinical development of biotherapeutics, safety issue resolution, communication and negotiation with global health authorities, and experience in writing regulatory documentation is required.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education:

• PhD in pharmacology, toxicology or a related biological science or an MD/DVM/PharmD or equivalent with a strong background or equivalent work experience.

Experience:
• At least 5 years experience in a nonclinical safety or closely-related scientific discipline (e.g. study director, project team toxicologist, biological sciences principal investigator); experience in intact animal studies (in vivo) and immunology (in vivo or in vitro) is particularly relevant to this position
• Demonstrated experience in the preclinical development of small molecules and biotherapeutics, complex issue resolution, written and verbal communication; negotiation with global health authorities and IND/CTA/NDA/BLA submission experience is desired.

• Experience with literature searches, database queries, in-silico assessments and data mining is desired

• Involvement in cross-industry organizations (discipline-related or related to drug development)
• Demonstrated ability to communicate clearly and succinctly to internal partners and health authorities.
• Understanding of regulatory submission components for registration including experience in authoring submission components in Documentum-like system.

Other Skills:
• Excellent interpersonal, leadership, organizational skills (e.g. planning and time management)
and teamwork skills
• Excellent oral and written communication and influencing skills ; ability to transform broad objectives into discrete study plans
• Highly efficient, self-motivated, flexible and able to work independently and efficiently under time constraints
• Ability to focus and work on several projects simultaneously and to integrate expectations and advice from discipline line units, TA Strategy teams and project teams in a matrixed environment
• Customer focused thinking
• Recognized ability to represent PCS on Novartis cross functional decision boards or other cross functional project teams
• Recognized expertise in technical and scientific problem solving in a project driven, multi-disciplinary international environment
• Ability to mentor and coach less-experienced colleagues
NIBR
Translational Medicine
USA
Cambridge, MA
NIBRI
Research & Development
Full Time
Regular