Scientific Director/Senior Scientific Director, Quantitative Clinical Pharmacology

Company: Takeda
Location: Boston
Posted on: November 20, 2023

Job Description:

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Job Description

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 Scientific Director/Senior Scientific Director of Quantitative Clinical Pharmacology in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Scientific Director/Senior Scientific Director of Quantitative Clinical Pharmacology working on the Quantitative Clinical Pharmacology team, you will be empowered to manage strategic, scientific and operational aspects of multiple drug development programs from the clinical pharmacology perspective, and a typical day will include:

POSITION OBJECTIVES:

• Leads strategic, scientific and operational aspects of multiple drug development programs with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence.
• Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
• Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
• Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
  
  ACCOUNTABILITIES:
  
  • Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple programs on Global Program Teams and associated scientific and operational sub-teams.
  • Charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum.
  • Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., SQS, QS and DMPK). Ensures that M&S plans are fully integrated with the larger program development plans to enable impactful Model-Informed Drug Development (MIDD) practices.
  • Works closely with colleagues in DSI, QS, and with external partners to ensure advanced modeling and simulation approaches (e.g., QSP, MBMA) inform internal decisions and external regulatory interactions.
  • Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting.
  • Responsible for clinical pharmacology summary documents for regulatory submissions (such as IB, CTA, CTD Module 2 documents, product labeling).
  • Maintains a high standard for good clinical practice, compliance and ethics.
  • Mentors junior staff to promote scientific excellence and individual achievement.
  • Represents Clinical Pharmacology in meetings with global regulatory agencies for assigned programs.
  • Participates as a member of Business Development due diligence, when requested.
  • Leads infrastructure initiatives and/ or cross-functional best practice initiatives.
    
    EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    
    • Scientific Director Level: Ph.D or Pharm D. w/ 12+ years or M.S. w/ +14 years or B.S. w/ +16 years of clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience.
    • Scientific Director Level: Ph.D w/ or Pharm D. w/ 15+ years or M.S. w/ 15-20 years or B.S. w/ 20-25 years of experience in clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience.
      
      Location and Salary Information:
      
      • Base Salary Range: $160,300 to $229,000, 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.
      • The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
        
        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 takedajobs.com .
          
          No Phone Calls or Recruiters Please.
          
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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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