Posted to MedZilla on 5/24/2017


Takeda Pharmaceuticals

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


 
 

OBJECTIVES:

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

ACCOUNTABILITIES:

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

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • 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.

LICENSES/CERTIFICATIONS:

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


we are driven to improve people's lives

www.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, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-MB2-USA


Schedule


Please visit our website at takedajobs.com

 
 


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