Principal Scientist Regulatory Toxicology
Posted on Apr 5, 2021 by Takeda Pharmaceuticals
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Principal Scientist, Regulatory/Development Toxicologist, in our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a member of the Drug Safety Research and Evaluation team you will be empowered to provide leadership and global functional expertise for projects in the Takeda portfolio.
This position is for a Toxicologist in the Drug Safety Research and Evaluation (DSRE) group at Takeda, located in Cambridge, MA. This person will serve as the DSRE project team member on multidisciplinary research and development teams, being responsible for design, reporting, and interpretation of regulatory nonclinical safety studies. This position will support programs across Takeda's 4 therapeutic areas: oncology, gastroenterology, neuroscience and rare diseases; and all the modalities used across those areas (eg, small molecules, protein therapeutics, oligonucleotides, oncolytic virus, and cell and gene therapies). As a member of multidisciplinary project teams, the individual will engage with other functional areas (eg, Regulatory Affairs, Manufacturing, Pharmacovigilance, and Clinical Research) to develop project plans and go/no-go decisions, in part by providing guidance on the necessary types of nonclinical studies and the implications from safety study findings on project plans/decisions. The individual must be able to articulate safety risks to a broad audience both internally and externally. Several years of experience working in a project team environment is required and the individual must be capable of a good degree of independent scientific thought.
The primary duties of this position include the following:
Serve as the DSRE team representative on development programs in GI, neuroscience, oncology and rare diseases across a range of modality types
Succinctly and effectively summarizes the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocols
Interact with Health Authorities, in writing and verbally
Interacts with other functional area experts in a project team environment to recommend the best course of action for a given program, and defend those recommendations to internal governance committees
Scientifically oversee the design, reporting and interpretation of exploratory and GLP-compliant outsourced safety studies and serve as study director on internal exploratory studies
Represents Takeda on partnered programs and at external venues such as scientific meetings
PhD in toxicology or related discipline, with 8+ years of applicable pharmaceutical experience; or MS with 12+ years of pharmaceutical experience
Several years of experience working in a multidisciplinary project team environment is required; experience in design, reporting, and interpreting safety studies is also required; and experience conducting GLP safety studies is a plus
Previous experience with oligonucleotide, oncolytic virus, or cell/gene therapies is highly desired but not mandatory
Good collaboration and communication skills working in team environments and in matrixed-management settings
Board certification is a plus (DABT or DAVBT)