Director, Translational Safety In Vivo Models

Organization
Novartis
Job Location
NA
East Hanover, NJ 07936
Job Description

The Director, Translational Safety In Vivo Models is part of the Preclinical Safety, Discovery and Investigative Safety team. Leading a group of molecular and cellular toxicologists in the design and implementation of in vivo and ex vivo models for predictive and mechanistic translational toxicology and for leading global strategic initiatives in nonclinical support of innovative medicines. 

Major Accountabilities : 
1. Lead group of molecular and cellular toxicologists in the design and implementation of in vivo and ex vivo models for predictive and mechanistic translational toxicology and direct support of studies leading to the initiation of clinical trials, achievement of registration for drug candidates, and competitive safety analysis. 
2. Develop strategy for bringing in state of the art molecular techniques, such as genome engineering, and apply them to prospective and retrospective in vivo and ex vivo evaluations of drug safety. 
3. Direct support to PCS target teams in generating an integrated, scientifically relevant and appropriately compliant nonclinical 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 ad-dress theoretical and identified issues (e.g. Clinical hold. Differentiation of com-pounds). 
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. 

EEO Statement 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.



Requirements: 

Minimum requirements Ideal Background: 

Education: PhD in pharmacology, toxicology, immunology, molecular biology, cell biology or a related biological science; MD, DVM, PharmD or equivalent with a strong in vivo, molecular and cell biology background or equivalent work experience. 

Experience: 
- At least 5 years experience in leading an in vivo laboratory. 
- Demonstrated experience in Advanced pharmacology/toxicology and molecular/cellular biology-based laboratory approaches for the development of in vivo/ex vivo disease models 
- In vivo genetic modification techniques including gene editing (constitutive/inducible gene knock-down/knock-out/knock-in; humanization) 
- In vivo cell transfer and tracking techniques, in particular for immune cells 

- 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. 
- nonclinical safety issue resolution 
- communication and negotiation with global health authorities 

- Excellent oral and written communication abilities: Able to make concise presentations customized for the audience and to clearly communicate and integrate nonclinical safety information with molecular pharmacology and other endpoints; able to anticipate questions and answer them clearly 
- Documented expertise in scientific and technical problem-solving: Able to effectively and independently lead target team to anticipate and analyze issues, identify key questions, and propose and prioritize activities for strategy team 
- An understanding of the drug development process and how investigative science plays a role in quickly and efficiently addressing key questions. 
- In depth knowledge of target/test system biology; able to integrate target and test system biology to interpret effects 
- Willing and able to use relevant information management tools generate data to formulate scientific hypotheses 
- Team skills: 
* Ability to manage conflicting expectations in a matrix environment. 
* Proven negotiation/influencing skills. 
* Excellent program and project management skills. 
* Able to work cooperatively and to adjust to team dynamics 
* Proactively communicates: anticipation of and respect for communication flow within PCS (eg Line functions and TAs) and within Novartis as a whole 
7. Self-motivated and able to operate independently

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