• Full Time
  • Anywhere

Scientific Director, Clinical Pharmacology-Location–Home Based

  • Provide global development science and strategic expertise to projects within a specific TA.  Provide regulatory expertise for clinical pharmacology registration within a specific TA
  • Have thorough understanding of exploratory development, clinical methodologies, POC, and clinical endpoints within a specific TA
  • Provide creative clinical pharmacology input for profiling of compounds to enable successful commercial differentiation
  • As a global clinical pharmacology lead for phase 3 programs, will ensure efficient delivery of clinical studies within a TA, under the responsibility for registration

 

Essential Job Responsibilities:

 

  • Provides disease area expertise and opportunities for scientific contributions to the team
  • Oversees interpretation of complex data, provides leadership in model based drug development, introduces “state-of-art” translation medicine strategies, platforms and methodologies
  • Defines and maintains a leading overall exploratory development and clinical pharmacology strategy.
  • Responsible for providing scientific oversight for preparation of various sections of regulatory documents, such as IB, IMPD and CTD.
  • Provides appropriate clinical pharmacology scientific input on licensing opportunities.
  • Contributes to the preparation of the capacity and budgetary information related to approved development projects, maintenance and marketing support projects, infra- structural projects and/or departmental activities
  • Contributes to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of clinical pharmacology
  • Be the Global Clinical Pharmacology Lead for in-house discovered or in-licensed compounds.
  • This requires leading a cross functional team of 15 — 25 experts in toxicology, pharmacology, translation, Clinical Pharmacology Operations. Responsible for delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration.

 

Quantitative Dimensions:

 

  • Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year
  • As a clinical pharmacology lead, provide the scientific lead for a cross-functional team of 15 – 25 people
  • Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.
  • Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registration
  • Has responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.

To apply for this job email your details to broseberry@cartermackay.com

CARTERMACKAY

400 Crown Colony Drive, Suite 600

 Quincy, MA 02169

T: 617-689-0029 • F: 617-689-3044

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