6500! That's the number of associates in the Novartis Institutes for Bio Medical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. Translational Medicine (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. As a Clinical Pathologist within the Preclinical Safety organization in TM, you will provide expertise to research and preclinical safety studies through well-written reports that accurately reflect data derived from standard clinical pathology endpoints as well as investigative biomarkers and immunotoxicological assessments. In conjunction with the study teams, you will contribute an integrated assessment of the significance of study findings to human safety within regulatory submission packages. In this role you will actively participate in the global drug development process through contributions as Project Pathologist on assigned drug targets and have the opportunity to serve as the safety assessment expert on project teams. In addition, you will work collaboratively within our pathology and investigative safety teams to build our scientific and technical expertise in translational biomarkers and technologies used to support safety studies and in-vivo safety models. Your main responsibilities will include: Effectively assess for pharmacological and toxicological effects of small molecules and biologics in preclinical studies, with a focus on clinical pathology, soluble biomarkers, and immunotoxicology. Collaborate with global team of pathologists and other scientists in design of preclinical safety studies and interpretation and communication of study findings, including the impact of the data on the safety profile and clinical development. Provide oversight of review of protocols, data, and reports generated at contract laboratories and maintain effective relationships with CRO clinical pathologists, scientists, and technical staff to ensure high quality, on-time reporting. Drive scientific and technical support for identification, development, qualification, and validation of translational biomarkers and immunological-based endpoints through collaboration with global biomarker and immunotoxicology teams and internal and external expert working groups. Support continuous development of laboratory analytical capabilities and career development of the technical team in collaboration with the laboratory manager. Serve as Project Pathologist on assigned compounds, targets, and therapeutic areas. Opportunity to participate as safety assessment expert on global drug development project teams.
JOB REQUIREMENTS: What you will bring to the role: A Doctor of Veterinary Medicine or equivalent related experience - Board Certification in Clinical Pathology by European/American College of Veterinary Pathologists (ECVP or ACVP) PhD in a biological science - Experience in toxicological pathology/clinical pathology - Experience preferred in development of novel biomarkers and/or immunotoxicological methods (flow cytometry, multiplex technology, immunoassays) and application in safety assessment, preferably within pharmaceutical/biotech or contract research organization - Good understanding of the drug development process, preferably including experience working directly on drug development project teams and Regulatory interactions and submissions - Excellent verbal and written communication skills - Ability to work cross-functionally within a team and matrix environment WHY CONSIDER NOVARTIS? 817 million. That's how many lives our products touched in 2018. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks. We are Novartis. Join us and help reimagine medicine
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. height=1 width=1 border=0 src=https://novartis.contacthr.com/71081554.jpg />
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Location/Region: Cambridge, MA (02138)