Posted to MedZilla on 5/27/2017


Takeda Pharmaceuticals

US-MA, Medical Director, Global Patient Safety - Early Stage Oncology 1601900-MZ


 
 

OBJECTIVES:
  • Support developmental programs in Oncology, including both early and late stage development as required.
  • Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibilities as appropriate.
  • Supporting Therapeutic Lead
  • Line management responsibilities for junior physicians and/or scientists
  • Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs
ACCOUNTABILITIES:
  • Expectation of Global Safety Lead (GSL) role for compound(s) both in development and marketed in close association with the Therapeutic Area Leader.
  • Company -wide safety expert for his/her compound responsibilities.
  • Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.
  • Serving in a leadership capacity for complex and strategically important programs
  • Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc.
  • Training and mentoring of Patient Safety Physicians and Specialists
  • Perform activities required to serve as Global Patient Safety physician:
    • Review and oversight of safety data, both non-clinical and clinical
    • Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
    • Interactions with external experts and regulatory agencies and partner/co-development companies
    • Review of safety data and participate in dose escalation decisions
    • Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
    • Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
    • Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities
Qualifications
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
  • Qualified physician (License, e.g. GMC registered, preferred)
  • Knowledge of principles of epidemiology and statistics.
  • Critical thinking and analytical skills and ability to make high level decisions
  • Excellent oral and written communication skills including ability to present to large internal/external groups
  • Good level of computer literacy with Microsoft applications


TRAVEL REQUIREMENTS:
Estimated 5-10 times per year including international travel



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Schedule
Full-time

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