Posted to MedZilla on 11/22/2019

Takeda Pharmaceuticals

US-MA, Scientific Director Toxicology Nonclinical Safety Assessment R0011387-MZ


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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientific Director Toxicology Nonclinical Safety Assessment in our Cambridge office.

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 Futureto people around the world.

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

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 multi-discipline 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. The programs will involve a broad range of modalities that include small molecules, protein therapeutics, oligonucleotides, and cell and gene therapies. As a member of multi-disciplinary project teams, the individual will engage with experts from other functions (e.g., Regulatory Affairs, Manufacturing, Pharmacovigilance, and Clinical Research) to develop project plans and go/no-go criteria, and then develop safety testing strategies that support the project plans and decision-making. The individual must be scientifically independent and able to articulate implications and risks from safety findings to a broad audience, as well as propose mitigation strategies when appropriate. The ideal candidate will also have experience in immunology-related targets, or cell- or gene-based therapies. The level of the position will be commensurate with experience.

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 areas, across a range of modality types
  • If appropriately experienced, provide guidance and recommendations to others in DSRE on safety assessments for immunology-related targets, or cell- or gene-based therapies.
  • Serve as study director on internal exploratory studies, and scientifically oversee the design, reporting and interpretation of exploratory and GLP-compliant outsourced safety studies
  • 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 program given the nonclinical safety risks, and defend those recommendations to internal governance committees
  • Represents Takeda in external venues, including scientific meetings and with potential partners
  • Provide evaluation for in-licensing opportunities that clearly articulate risks and recommendations for mitigating risks


  • PhD in toxicology or related discipline, with 8+ years of applicable pharmaceutical experience; or MS with 13+ years of pharmaceutical experience
  • Experience in design, reporting, and interpreting safety studies, and experience in the conduct GLP studies
  • Good collaboration and communication skills working in team environments and in matrixed-management settings
  • Board certification is desired (DABT or DAVBT)


  • 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

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Boston, MA

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Full time

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