Clinical Pathologist, Preclinical Safety

Job Description Summary

#LI-Hybrid

Internal title: Senior Principal Scientist


This position will be located at our Cambridge MA or East Hanover, NJ site (Cambridge, MA preferred) and will not have the ability to be located remotely.

About the role:

As a Clinical Pathologist within the Preclinical Safety organization within BR's Translational Medicine organization, you will apply your expertise to research and preclinical safety studies through sound scientific assessment and integration of laboratory data, including non-traditional safety biomarker results, and providing, and reviewing for well-written interpretive reports. You will contribute to an integrated understanding of the patho mechanisms and human safety significance of non-clinical study findings as well as actively participate in the drug development decisions through input as Project Pathologist on a diverse portfolio of drug platforms and targets, and have the opportunity to lead investigations for preclinical safety issue resolution.

 

Job Description

Key responsibilities:

• Effectively assess for toxicological and pharmacological effects of small molecules and biologics in preclinical studies, with a focus on clinical pathology and relevant soluble biomarkers.

• Collaborate with global teams 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 expert review of protocols, results, 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.

• Contribute to scientific and technical support for identification, development, qualification, and validation of translational biomarkers targeted to support study safety assessments.

• 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

• Keep up to date on scientific literature relevant to your work on project and target teams, and to novel soluble biomarkers and applicable technologies

Essential Requirements:

- A Doctor of Veterinary Medicine (DVM) or equivalent related experience

- Board Certification in Clinical Pathology by American/European College of Veterinary Pathologists (ACVP or ECVCP)

- Preferred PhD in a biological science

- Some experience in toxicological pathology desired

- Experience preferred in development of novel biomarkers and immunoassays and/or other technical immunological methods (flow cytometry, multiplex technology, etc.), and application in safety assessment, preferably within pharmaceutical/biotech or contract research organization

- Experience preferred in interpreting clinical pathology data for laboratory animals, including nonhuman primates and rodents

- Some understanding of the drug development process, preferably including experience working directly on drug development project teams and Regulatory interactions and submissions preferred

- Excellent verbal and written communication skills- Ability to work cross-functionally within a team and matrix environment

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Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $183,200 and $274,800/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on