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Senior Medical Director, Head of Risk Management and Organ Toxicity

応募後で応募 求人ID R0045142 掲載日 08/19/2021 Location:Boston, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Medical Director, Head of Risk Management and Organ Toxicity (RiMOT) Center of Excellence, in our Cambridge, Massachusetts office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Senior Medical Director, Head of Risk Management and Organ Toxicity (RiMOT) CoE, working on the GPSE team, you will be empowered to oversee RiMOT CoE and ensure it provides subject matter expertise in Risk Management, Benefit/Risk assessment, Organ Toxicity and its mitigation strategies to the Global Medical Safety teams in Global Patient Safety Evaluation (GPSE) as well as the larger cross-functional and global product teams.  A typical day will include:

POSITION OBJECTIVES:

  • Ensures that GPSE Risk Management (RM), Benefit/Risk (B/R), Organ Toxicity identification and mitigation processes are continuously improved to reflect regulatory trends/guidelines, represent best practices, and remain aligned with the GPSE governance model
  • Establish a culture of excellence in RM, B/R, Organ Toxicity and its mitigation, and ensure that members of the department of Risk Management and Organ Toxicity are provided with the appropriate development and management to provide the strategy and leadership in RM, B/R, and Organ Toxicity in GPSE and to the cross-functional and global product teams
  • Maintain collaborative working environment with the LOCs, vendors and consultants

POSITION ACCOUNTABILITIES:

Excellence in Risk Management and Benefit/Risk, and Organ Toxicity Identification and Mitigation Strategies

  • Develop and execute the overall vision and strategy for RiMOT CoE in GPSE and across the larger Takeda organization
  • Provide leadership and expertise to ensure consistency of product RM and B/R assessment, and early identification and mitigation of organ toxicity globally across all therapeutic areas (e.g.Oncology, RGH,GI, and CNS), and business units (Plasma-derived Therapies and Vaccine)
  • Support Global Safety Leads (GSLs) in their activities to provide strategic leadership in relation to RM, B/R and Organ toxicity within GPSE and the cross-functional and global product teams
  • Provide subject matter expertise and/or support RiMOT CoE subject matter expertise provision during inspections
  • Educate members of GPSE, cross-functional global product teams, and the larger Takeda organization on the disciplines of Risk Management, Benefit/Risk Assessment, Organ Toxicity identification and mitigation, and the changing regulatory environment around them
  • Contribute to B/R discussions with GPSE 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, and Organ toxicity identification, evaluation, and mitigation processes
  • Work with LOCs to facilitate the selection of vendors, review and approval of SOWs for additional Risk Minimization Materials (aRMMs)

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
  • Understand signal detection processes and help support training in signal detection to GPSE and other global functions 
  • Engage with vendors and external experts supporting RM and B/R activities

Organ Toxicity Processes

  • Provides general oversight of the identification, evaluation and mitigation of target organ toxicity processes across therapeutic areas
  • Oversee the constitution of expert and/or adjudication committees to evaluate identified organ toxicities
  • Work with VP Medical Safety RGH and PDT to identify potential internal and external experts to serve on Adjudication Committees

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, BEHAVIORAL COMPETENCIES AND SKILLS:

Education/Experience

  • Advanced degree in life sciences required. Preferred qualifications: MD, DO PharmD or international equivalent or Doctoral degree in relevant life sciences
  • Minimum of 10 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

This job posting excludes CO applicants

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

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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