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Scientist Regulatory Toxicologist, Non-Clinical Safety Assessment

Company: Takeda
Location: Somerville
Posted on: January 14, 2021

Job Description:

By clicking the ---Apply--- button, I understand that my employment application process with Takeda will commence and that I agree with Takeda---s Privacy Notice, Privacy Policy and Terms of Use.Job DescriptionAre 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 Scientist, Regulatory Toxicologist, Non-Clinical Safety in our Cambridge, Massachusetts office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a vital member of the Drug Safety Research and Evaluation team, you will be empowered to provide leadership and global functional expertise for projects across 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 (e.g., 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 (e.g., 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.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 typesSuccinctly and effectively summarizes the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocolsInteract with Health Authorities, in writing and verballyInteracts 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 committeesScientifically oversee the design, reporting and interpretation of exploratory and GLP-compliant outsourced safety studies and serve as study director on internal exploratory studiesRepresents Takeda on partnered programs and at external venues such as scientific meetingsRequirements:PhD in toxicology or related discipline, with years 5 to 8 years of applicable pharmaceutical experience; or MS with 9 to 12 years of pharmaceutical experienceExperience in design, reporting, and interpreting safety studies is required, and experience in the conduct GLP studies is a plusSeveral years of experience working in a multidisciplinary project team environment is requiredPrevious experience with oligonucleotide, biologic, or cell/gene therapies is a plus but not mandatoryGood collaboration and communication skills working in team environments and in matrixed-management settingsBoard certification is a plus (DABT or DAVBT)WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to ShineLearn more at takedajobs.com.Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit No Phone Calls or Recruiters PleaseLI-KL1LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeFull time

Keywords: Takeda, Somerville , Scientist Regulatory Toxicologist, Non-Clinical Safety Assessment, Healthcare , Somerville, Massachusetts

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