Posted to MedZilla on 5/24/2017

Takeda Pharmaceuticals

US-MA, Oncology - Drug Safety Therapeutic Lead 1700946-MZ



For the Oncology Therapeutic Area (TA):
  • Provides scientific and strategic guidance, and matrix oversight for all DSRE project team representatives working on oncology programs
  • DSRE management accountable person overseeing the oncology portfolio, ensuring that the strategy DSRE is taking is in alignment with other functions in discovery and development
  • Guides, mentors, and provides performance feedback for DSRE project representatives working on oncology programs


For the Oncology Therapeutic Area (TA):

  • Interact directly with DDU and TAU head (or designee) to determine goals, strategy and execution of the development of drug candidates
  • Provide scientific and strategic expertise to DSRE project representatives for the development of oncology drug candidates
  • Review and advise on data, reports, scientific conclusions and presentations
  • Approve DSRE components of clinical development plans.
  • Keep current on the latest trends in the competitive and regulatory landscape particularly as it relates to oncology therapeutics
  • Align goals and resources with DDU and TAU, and communicate those needs to DSRE Operations Head and Site Head(s), and other functional heads, as needed
  • Review and approve regulatory documents and correspondence



  • PhD and/or DVM
  • Approximately fifteen years of pharmaceutical experience with biologics and small molecules, roughly half of which has been spent handling safety assessment of biologics
  • Experience in all stages of drug development and in making recommendations to senior management of other line functions regarding key program decisions
  • Experience in regulatory submission (INDs, CTA, NDAs, MAAs) and in health authority interactions, and in developing strategies around those interfaces
  • Experience in managing and conducting GLP studies and regulatory inspections
  • Excellent communication, matrix management, and mentorship skills.


  • Board Certification in Toxicology, Pathology, or related discipline highly desired
  • Routine demands of an office based environment.
  • US/International travel to Takeda sites, partners or regulators as needed

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