Clinical Pharmacologist/Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology

Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: January 19, 2023

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 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 Clinical Pharmacologist/Senior Clinical Pharmacologist , Quantitative Clinical Pharmacology in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Clinical Pharmacologist/Senior Clinical Pharmacologist working on the 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 (Modeling and Simulation) 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).
  • Oversees and/or independently performs pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners.
  • 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:
    • Clinical Pharmacologist Level: Ph.D or Pharm D. w/ 0+ years or M.S. w/ +2 years or B.S. w/ +5 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
    • Senior Clinical Pharmacologist Level: Ph.D w/ or Pharm D. w/ 3+ years or M.S. w/ 4+ years or B.S. w/ 6+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience Location and Salary Information:
      
      This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy."
      
      Base Salary Range: $130,200 to $186,000, 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
      
      Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
      
      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 .
        
        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
        
        USA - MA - Cambridge
        
        Worker Type
        
        Employee
        Worker Sub-Type
        
        Regular
        Time Type
        
        Full time

Keywords: Takeda Pharmaceutical, Cambridge , Clinical Pharmacologist/Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology, Other , Cambridge, Massachusetts