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Regulatory Toxicologist – Nonclinical Safety Assessment, Scientist II

応募後で応募 求人ID R0065524 掲載日 05/10/2022 Location:Boston, Massachusetts

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Job Description

Regulatory Toxicologist – Nonclinical Safety Assessment, Scientist II

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Regulatory Toxicologist in our Cambridge, MA.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Regulatory Toxicologist – Nonclinical Safety Assessment, Scientist II working on the Drug Safety Research and Evaluation (DSRE) team, you will be empowered to Serve as the DSRE team representative on development programs in GI, neuroscience, oncology and rare diseases across a range of modality types.

A typical day will include:

POSITION OBJECTIVES:

  • Responsible for design, reporting, and interpretation of regulatory nonclinical safety studies.
  • Support programs across Takeda’s 4 therapeutic areas: oncology, astroenterology, neuroscience and rare diseases; and all the modalities used across those areas (e.g., small molecules, protein therapeutics, oligonucleotides, cell engagers, and cell and gene therapies).
  • 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.

POSITION ACCOUNTABILITIES:

  • 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
  • Interact 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

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • PhD in toxicology or related discipline, with 2+ years of applicable pharmaceutical experience; or MS with 9+ years of pharmaceutical experience
  • Experience in design, reporting, and interpreting safety studies, and experience in the conduct GLP studies
  • At least 2 years of experience working in a multidisciplinary project team environment
  • Previous experience with oligonucleotide, cell engagers, cell/gene therapies, or non-traditional small molecules is a plus, but not required
  • Good collaboration and communication skills working in team environments and in matrixed-management settings
  • Board certification is a plus (DABT or DAVBT)

Takeda U.S. Vaccine Requirement:

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

*KB-LI

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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