The Head of Toxicology and Pathology (tox/path) Sciences leads the organization in our understanding of the biological and potential adverse effects of modified mRNA’s in preclinical species with an eye towards translating these potential effects to humans and establishing the regulatory position supporting these agents in clinical trials.
• Build and lead an appropriately-sized group of top tox/path scientists.
• 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.
• Establish relationships with the leading CRO’s for conduct of GLP studies with modified mRNA’s.
• Interface with the drug metabolism and pharmacokinetic experts to characterize the full pharmaco and toxicodynamic properties of this novel class of agents.
• Prepare appropriate sections of regulatory documents to support the filing of applications for human dosing including IND’s, CTA’s, etc. and represent the company at Agency meetings as needed.
• DVM and/or Ph.D. in comparative pathology (ACVP board certification preferred), pharmacology and/or toxicology with 6 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 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 toxicologic/pathology skills to interpret chemical based toxicity and morphological/clinical pathology changes related to chemical exposures.
• Experience conducting outsourced GLP toxicology studies and interfacing with the scientific tox/path staffs at leading CRO’s.
• Exceptional leadership capabilities and team building experience with a record of proven organizational success.
• Effective communication (written and oral).
• Detail orientation.
• Results orientation.
• Sense of urgency.
Why join Moderna Therapeutics:
Moderna Therapeutics is pioneering messenger RNA therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn active intracellularly or secreted. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate including 200 patent applications with 10,000 claims ranging from novel nucleotide chemistries to specific drug compositions. The company plans to develop and commercialize its innovative mRNA drugs—initially for rare diseases and oncology—while partnering drug candidates in other therapeutic areas in order to rapidly deliver this innovation to patients.
Based in Cambridge, Massachusetts, Moderna is privately held and was founded in 2010 by Flagship VentureLabs in association with leading scientists from Harvard University and Massachusetts Institute of Technology.
Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Visit http://modernatx.com/revolution to apply.