Associate Director, Clinical Pharmacology and Development

6 days ago


North Chicago Illinois, United States AbbVie Full time
Job Summary

We are seeking an experienced Associate Director, Clinical Pharmacology and Development to join our team at AbbVie. This role will be responsible for conceiving, executing, and managing clinical pharmacology development plans and strategies that achieve commercial goals and regulatory requirements.

Key Responsibilities
  • Develop and execute clinical pharmacology development plans and strategies that align with AbbVie's commercial goals and regulatory requirements.
  • Lead the development of new PK/PD study proposals and oversee their execution.
  • Anticipate and critically evaluate clinical pharmacology, PK/PD, and regulatory advances, and respond with appropriate new strategies.
  • Consistently demonstrate a strong record of accomplishment in clinical pharmacology and business objectives.
  • Lead clinical pharmacology/PK/PD aspects of multiple projects and critically evaluate technical and scientific aspects.
Accountabilities
  • Accountable for Phase 1-4 studies design and clinical pharmacology strategy.
  • Represent the project(s) at various meetings and present at departmental and cross-functional teams.
  • Author regulatory documents, including protocols, study reports, and CTDs.
  • Drive small teams to provide a unified clinical pharmacology position to clinical, CMC, and regulatory teams.
  • Represent Clinical Pharmacology at regulatory meetings.
Requirements
  • Ph.D. in Pharmacology, Pharmaceutical Sciences, or a related field.
  • Minimum 8 years of experience in clinical pharmacology and development.
  • Proven track record of accomplishment in clinical pharmacology and business objectives.
  • Strong leadership and communication skills.


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