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location: Cambridge, Massachusetts
job type: Permanent
salary: $130,000 - 140,000 per year
work hours: 8 to 4
Reporting to the Director of Pathology, supporting the characterization and the understanding of potential adverse effects of modified mRNA's and delivery systems in preclinical species. Helping uncover the molecular pathogenesis behind these changes to understand if these effects translate to the clinical situation. In addition, supporting the effort for developing better, safer and more efficient delivery and expression system. Finally, providing support to establish the regulatory position to enable clinical trials with these agents.
- Support the development and execution of pathology sciences laboratory internally to support the platform and subsidiary specific needs (molecular pathology, histology, investigative pathology/toxicology)
- Support the effort to establish state of the art processes for evaluating and characterizing the effects of modified mRNA's in preclinical species including the pathology sciences necessary for this characterization.
- Interface with the drug metabolism and pharmacokinetic experts to characterize the full pharmaco- and toxicodynamic properties of this novel class of agents.
- Helping to develop the pathology assessment scheme for potential clinical candidates, up to and including peer-review of GLP and regulatory enabling studies
- Prepare appropriate sections of regulatory documents to support the filing of applications for human dosing including IND's, CTA's, etc.
- DVM and/or Ph.D. in comparative pathology (ACVP board certification preferred), pharmacology and/or toxicology with 5 or more years spent overseeing all aspects of the Safety Assessment activities in pharmaceutical development. Strong consideration will be given to those with experience in the evaluation of nucleic acid-based and nanoparticle tox/path.
- Significant contributions to the success of novel pharmaceutical agents with direct experience authoring study reports and appropriate sections of regulatory documents supporting applications for human dosing.
- Strong investigative toxicologic/pathology skills to interpret chemical based toxicity and morphological/clinical pathology changes related to chemical exposures.
- Strong level of understanding and expertise in either one or more of the following: immunology, nanoparticle biology and pathology, the complement system
- Experience conducting outsourced GLP toxicology studies and interfacing with the scientific tox/path staffs at leading CRO's.
- Candidate will be curious in exploring new path for drug discovery, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
skills: IND, Toxicology, GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.