Principal Scientist Regulatory Toxicologist, Non Clinical Safety Assessment

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Cambridge, Massachusetts

Expiry Date :
Mon, 05 Apr 2021 23:59:59 GMT

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Principal Scientist Regulatory Toxicologist, Non-Clinical Safety Assessment By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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 (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 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 Requirements: – 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) This job posting excludes CO applicants WHAT TAKEDA CAN OFFER YOU: – 401(k) with company match and Annual Retirement Contribution Plan – Tuition reimbursement – Company match of charitable contributions – Health & Wellness programs including onsite flu shots and health screenings – Generous time off for vacation and the option to purchase additional vacation days – Community Outreach Programs Empowering Our People to Shine Learn more at . 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 Please #LI-KL1 Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time