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AIRx, Sr. Director, Nonclinical Safety Lead (BOSTON)

Date Posted: Jun 28, 2026
Yearly: USD - USD
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Job Detail

  • location_on
    Location Cambridge, Massachusetts, United States of America
  • desktop_windows
    Job Type: Permanent
  • schedule
    Shift:
  • analytics
    Career Level:
  • group
    Positions:
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    Experience:
  • male
    Gender: No Preference
  • school
    Degree:
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    Apply Before: Sep 26, 2026
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Job Description

Overview

The Sr. Director of Nonclinical Safety Lead at Takeda Pharmaceutical will play a crucial role within the AIRx team in Cambridge, Massachusetts. This position involves designing and executing nonclinical safety strategies for drug candidates while leveraging AI and data analytics to support decision-making in the biopharmaceutical development process.

Key responsibilities

  • Own the nonclinical safety strategy across the AIRx portfolio, including small molecule and biologics projects.
  • Design and oversee CRO-executed safety studies, writing and reviewing protocols and interpreting data packages.
  • Integrate safety data into AI-enabled DMTA cycles, collaborating with chemistry and biology teams.
  • Lead early safety screening, including toxicity predictions and organ-toxicity assessments.
  • Author nonclinical sections of INDs and CTAs, representing Takeda in regulatory interactions.
  • Stay updated on regulatory guidance and assess implications for program timelines.
  • Shape practices for nonclinical safety in the AIRx model.

Required skills

  • PhD in toxicology, pharmacology, biochemistry, or related field
  • 12-15+ years of pharmaceutical drug discovery experience
  • Expert knowledge of ICH guidelines and regulatory expectations
  • Deep expertise in genetic toxicology and safety pharmacology
  • Proficiency in early safety screening techniques and assays
  • Experience directing CRO safety study packages
  • AI/ML data literacy and ability to integrate large safety datasets
  • Excellent cross-functional collaboration and communication skills

What the company offers

  • Hybrid work environment in Cambridge, MA

Skills Required

Company Overview

Takeda Pharmaceutical
Cambridge, Massachusetts, United States of America
24 Current Jobs Openings

Takeda Pharmaceutical is a global biopharmaceutical company committed to bringing better health and a brighter future to people worldwide. We focus on developing innovative medicines based on profound science and patients' needs, actively engaging in... Read More

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