Senior Investigator, Discovery and Investigative Safety, PCS

234160BR
Senior Investigator, Discovery and Investigative Safety, PCS
Leading a team of molecular and cellular toxicologists in the design and implementation of investigative safety endpoints and models to support in vivo, ex vivo and in vitro mechanistic translational toxicology studies, with a particular emphasis on comparative biology of innovative therapeutics with unique mechanisms of action and/or use of advanced modalities such as gene and cell therapies. Leading strategic safety science initiatives for nonclinical support of innovative medicines and input for global project teams.

1. Lead group of molecular and cellular toxicologists in the design and implementation of investigative safety endpoints and models to support in vivo, ex vivo and in vitro mechanistic translational toxicology studies. To direct investigative safety studies that support de-risking of innovative drug targets and modalities, non-clinical compound candidate selection, initiation of clinical trials, registration for drug candidates, and competitive safety analysis. 2. Develop strategy for bringing in state of the art molecular and cellular techniques, and apply them to prospective and retrospective in vivo, ex vivo and in vitro evaluations of drug safety, with a particular emphasis on comparative biology of innovative therapeutic targets, pathways and modalities. 3. Provide support to PCS target teams in generating an integrated, scientifically relevant and appropriately compliant nonclinical investigative safety assessment plan to support development/registration of drugs of various and novel modalities. 4. Direct team to scientifically design issue management/resolution studies to address theoretical and identified issues (e.g. clinical hold. differentiation of compounds). 5. Timely communication to PCS and project teams regarding a. theoretical or observed safety effects, their impact and proposed plans to address them. b. resource requirements to execute nonclinical safety assessment plan. 6. Clear, concise and correct communication of nonclinical safety results and their impact to HA and investigators. 7. Positive recognition of PCS within Novartis. 8. Positive recognition of Novartis within the drug development community and society as a whole.
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.
PhD in pharmacology, toxicology, immunology, molecular biology, biochemistry, cell biology or a related biological science; MD, DVM, PharmD or equivalent with a strong mo-lecular and cell biology back Fluent English (oral and written). • At least 5 years experience in leading a molecular or cellular biology laboratory. • Demonstrated experience in o Advanced pharmacology/toxicology and molecu-lar/cellular biology-based laboratory approaches o In vitro gene modification techniques (e.g. tools for constitutive/inducible gene knock-down/knock-out/knock-in, modification of protein stability/degradation and humanization) o In vitro/ex vivo molecular and cellular assays for assessing immune cell interactions and functions • Demonstrated leadership in cross-industry organization • An understanding of the drug development process and how investigative science plays a role in quickly and efficiently addressing key questions. o nonclinical safety issue resolution o communication and negotiation with global health authorities
NIBR
Translational Medicine
USA
Cambridge, MA
NIBRI
Research & Development
Full Time
Regular