Posted to MedZilla on 9/19/2017


Takeda Pharmaceuticals

US-MA, Senior Director, Risk Management and Benefit/Risk 1701071-MZ


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Risk Management and Benefit/Risk in ourCambridge office.


OBJECTIVES:
  • Oversee the department of Risk Management and Benefit Risk and ensure it provides subject matter expertise in Risk Management and Benefit/Risk assessment to the Global Medical Safety teams in Global Patient Safety (GPS) as well as the larger cross-functional product teams
  • Ensures that GPS Risk Management (RM) and Benefit/Risk (B/R) processes are continuously improved to reflect regulatory trends/guidelines, represent best practices, and remain aligned with the GPS governance model
  • Establish a culture of excellence in RM and B/R and ensure that members of the department of Risk Management are provided with the appropriate development and management to provide the strategy and leadership in RM and B/R in GPS and to the cross-functional product teams
  • Maintain collaborative working environment with vendors

ACCOUNTABILITIES:

Excellence in Risk Management Strategy and Benefit/Risk
  • Develop and execute the overall vision and strategy for Risk Management and Benefit/Risk in GPS and across the larger Takeda organization
  • Provide leadership and expertise to ensure consistency of product RM and B/R assessment globally across all therapeutic areas (e.g.Oncology, GI, and CNS)
  • Support the Risk Management Leads (RMLs) in their activities to provide strategic leadership within GPS and the cross-functional product teams
  • Provide subject matter expertise and/or support RML subject matter expertise provision during inspections
  • Educate members of GPS, cross-functional product teams, and the larger Takeda organization on the disciplines of Risk Management, Benefit/Risk Assessment, and the changing regulatory environment around them
  • Contribute to B/R discussions with GPS senior management as indicated
  • Facilitate links with regulatory agency advisory groups, academic centers, and advocacy organizations to ensure cutting edge knowledge and application of RM and B/R regulations and best practices
Risk Management and B/R Processes
  • Provides general oversight of RMP development and submission tracking globally across therapeutic areas
  • Provides general oversight of the assessment, development, validation and the implementation of required additional risk minimization measures globally across therapeutic areas
  • Accountable for all RM and B/R processes to ensure they reflect current regulatory trends and best practices; facilitate the update of SOPs or other functional documents as needed
  • Engage with partner global functions (e.g. Regulatory Affairs, Clinical Science/Research) to ensure alignment of global processes and minimize duplication
  • Work with the Risk Management Scientist in his/her efforts to provide maximal operational support to the Risk Management team
  • Understand signal detection processes and help support training in signal detection to GPS and other global functions
  • Engage with vendors and external experts supporting RM and B/R activities
Culture/Environment
  • Dedicated expertise and time to provide strong leadership and management to the RM and B/R team members in a manner that promotes their growth and development
  • Establish strong presence of the RM and B/R group in GPS and in the larger Takeda organization
  • Oversee and delegate the RM and B/R workload among the RM and B/R team

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education/Experience
  • Advanced degree in life sciences required
  • Minimum of 12 years of pharmaceutical/device industry experience, with at least 5 years in Pharmacovigilance and Risk Management
  • Prior leadership and management experience
  • Ability to work across multiple therapeutic areas
  • Experience liaising with regulatory agencies, professional groups and/or academic centers
  • Strong track record of scientific and analytical thinking
Competencies and Skills
  • Integrity
  • Ability to relate well to people and to motivate and empower others
  • Insights required to work productively in global company and across multiple functions
  • Communication with clarity and brevity
  • Capacity to take initiative and work productively in a high pressure environment
  • Strong knowledge of business area and understanding of the proactive interactions necessary to achieve business goals and objectives
  • Capacity to manage time and priority constraints as well as manage multiple priorities simultaneously
  • Ability to lead meetings and teleconferences, both internally in Takeda as well as externally to technical and lay groups and public meetings
  • Attention to detail
  • Computer literacy including knowledge of safety database

PHYSICAL DEMANDS:

  • Consistent with those required for office-based work
TRAVEL REQUIREMENTS:
  • Some domestic and international may be required on an infrequent basis

WHAT TAKEDA CAN OFFER YOU:

  • 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

Learn more at 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, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

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Schedule

Please visit our website at takedajobs.com

 
 


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