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Senior Director, Pharmacometrics- Quantitative Clinical Pharmacology

Company: Takeda Pharmaceutical
Location: South Hamilton
Posted on: November 26, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 Head and Senior Director, Pharmacometrics, Quantitative Clinical Pharmacology. 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. OBJECTIVES:

  • The Senior Director manages strategic, scientific and operational aspects of pharmacometrics across multiple drug development programs within the Global Clinical Pharmacology (QCP) with a high level of technical and strategic independence.
  • Works closely with functional experts within QCP and across the R&D organization: Research, Biostatistics, Regulatory Affairs, DMPK, Pharm Sci, and Clinical Science, providing leadership and guidance for modeling and simulation.
  • Contributes to departmental management through program reviews and collaborative decision-making and leads infrastructure / best practice initiatives. Supervises and mentors junior staff providing professional and career development.
  • Establishes a mindset of continuous improvement, best-practice, business-focused resourcing strategy ACCOUNTABILITIES:
    • Provides scientific and strategic leadership as the pharmacometrics Head for multiple programs, working with QCP Therapeutic Areas
    • Ensures drafting and executing modeling and simulation plans, including integration of M&S, in collaboration with key partner functions. Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans to enable Model-Informed Drug Development (MIDD).
    • Works closely with colleagues to ensure strategic integration of advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum to inform internal decisions and external regulatory interactions.
    • Responsible for modeling and simulation content in clinical pharmacology summary documents (such as IB, CTA, CTD Module 2 documents, product labeling).
    • Oversee and/or independently perform pharmacometric analyses including the interpretation and associated statistical analyses in close partnership with external CRO partners.
    • Maintains a high standard for good clinical practice, compliance and ethics.
    • Mentors junior staff to ensure they value scientific excellence.
    • Represents Clinical Pharmacology in meetings with global regulatory agencies for model-based drug development
    • Participates as a member of Business Development due diligence, when required.
    • Leads infrastructure initiatives and/ or cross-functional best practice initiatives. CORE ELEMENTS RELATED TO THIS ROLE
      • This role will be expected to be the primary point of accountability in QCP at the asset level on aspects of model-based drug development across multiple therapeutic modalities with a high level of technical and strategic independence.
      • The individual has extensive experience both technical strategic scientific leadership, project planning, and decision making from a pharmacometric perspective with a strong enterprise mindset. S/he will thus be expected to lead infrastructure and/ or best practice initiatives.
      • Externally recognized for leadership demonstrating a sustained record of scientific productivity in the field of modeling & simulation, as evidenced by the development and/or implementation of numerous new technical strategies, methods, processes, and publications.
      • Advance the discipline of pharmacometrics and integrate emerging areas in the quantitative arena (Artificial Intelligence, Machine Learning) EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
        • Ph.D or Pharm D. w/ -15 years or M.S. w/ -20 years or B.S. w/ -25 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience. Location and Salary Information: Base Salary Range: $194,600 to $278,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy." 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 . No Phone Calls or Recruiters Please. 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

Keywords: Takeda Pharmaceutical, Boston , Senior Director, Pharmacometrics- Quantitative Clinical Pharmacology, Executive , South Hamilton, Massachusetts

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