Posted to MedZilla on 3/20/2019


Takeda Pharmaceuticals

US-MA, Associate Scientific Director/Scientific Director - Quantitative Clinical Pharmacology (Oncology) R0006515-MZ


 
 

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Job Description

Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Our US Offices are in Cambridge, MA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.

While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

  • The Associate Scientific Director/Scientific Director manages strategic, scientific and operational aspects of multiple oncology/immuno-oncology programs from the clinical pharmacology perspective.
  • Serves as the Global Clinical Pharmacology Lead for assets across phases 1-4 of development. Works closely with functional experts across the R&D organization, such QS, Research, Biostatistics, Regulatory Affairs, DMPK, Pharm Sci, and Clinical Science providing leadership and guidance in clinical pharmacology activities.
  • Assists in departmental management through program reviews and collaborative decision-making.
  • Supervises and mentors junior staff providing professional and career development.

ACCOUNTABILITIES:

  • Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple oncology/immuno-oncology programs on Global Program Teams and associated scientific and operational sub-teams.
  • Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., QS and DMPK). 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 in QS 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.
  • 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 (such as IB, CTA, CTD Module 2 documents, product labeling).
  • Oversee and/or independently perform PK/PD analyses including the interpretation of PK/PD data 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 his/her assigned programs.
  • Participates as a member of Business Development due diligence, when required.

Technical/Functional (Line) Expertise

  • Demonstrated expertise in application of PK/PD, modeling and simulation, and use of clinical biomarkers for decision making.
  • Demonstrated scientific and technical expertise through publications, patents, awards/honors or credibility at professional societies. Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science.
  • Demonstrated experience with design and analysis of clinical pharmacology studies.
  • Knowledge of tumor immunology with demonstrated experience in the development of immuno-oncology therapies and novel therapeutic modalities (e.g., bi-specifics, ADCs, cellular therapies) is highly desirable.

Leadership

  • Effective at building alliances across functions.
  • Excellent interpersonal communication skills, able to drive global collaborations in cross-functional, multi-cultural organizations.
  • Excellent oral and written communication skills, including writing, reviewing and editing scientific documents.
  • Ability to effectively influence colleagues and multi-disciplinary project teams.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • Ph.D or Pharm D. w/ 10+ years or M.S. w/ +12 years or B.S. w/ +15 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience. (Associate Scientific Director level)
  • Ph.D w/ or Pharm D. w/ 12+ years or M.S. w/ 14+ years or B.S. w/ 16+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience. (Director level)

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.

#LI-MH1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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