Posted to MedZilla on 4/30/2017


Takeda Pharmaceuticals

US-MA, Scientific Director, Quantitative Clinical Pharmacology 1602886-MZ


 
 

OBJECTIVES:

  • The Associate Scientific Director manages strategic, scientific and operational aspects of programs from the clinical pharmacology perspective.
  • Serves as the clinical pharmacology program lead for compounds in Phase 1-4 clinical studies. Works closely with functional experts across the R&D organization, such QS, DMPK, Research, Pharm Sci, TBR, 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.
  • Co-leads cross-functional efforts.

ACCOUNTABILITIES:

  • Provides representation and leadership on strategic and operational cross-functional teams.
  • Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with QS and DMPK. Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans.
  • Works closely with colleagues in QS to ensure appropriate quantitative support for the program is achieved.
  • Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis, resolution of internal decision points and external regulatory interactions.
  • Responsible for clinical pharmacology summary documents (such as IB, CTA).
  • Performs PK/PD analyses or guides such analyses as appropriate.
  • Maintains a high standard for good clinical practice, compliance and ethics.
  • Mentors junior staff to ensure they value scientific excellence.
  • Represents Takeda QCP in meetings with regulatory agencies and Health Authorities.
  • When required participates as a member of Business Development due diligence.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Ph.D. or equivalent degree + 5-7 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
  • Pharm.D. +7 years of clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience.
  • M.S. +10 years of clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience.
  • B.S. + 15 years of clinical pharmacology, pharmacokinetic, pharmacometrics, other relevant experience.
  • Educational degree in a relevant scientific area, e.g., Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy, or other related area.
  • 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.
  • Excellent understanding of and interests in PK/PD, modeling and simulation, and use of clinical biomarkers for decision making.
  • Effective at building alliances across functions.
  • Excellent interpersonal communication skills, able to drive global collaborations in cross-functional, multi-cultural organizations.


PHYSICAL DEMANDS:

  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:
  • Access to transportation to attend various meetings held in proximity to the Takeda offices.
  • Able to attend meetings at investigator, vendor or regulatory agency sites.
  • Some international travel may be required.


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Schedule
Full-time

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