Scientist Regulatory Toxicologist, Non-Clinical Safety Assessment
Company: Takeda
Location: Somerville
Posted on: January 14, 2021
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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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