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Associate Director, Clinical Pharmacology
4 months ago
Join a Legacy of Innovation 110 Years and Counting
Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.
Summary
The Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/ Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and development teams.
Responsibilities
- Responsible for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with high-level supervision; participates in due diligence activities and represents global function on study and project teams
- Produces independent writing for publications & regulatory documents
- Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and can conduct/develop PK-PD and Pop PK-PD analyses,
- Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management, and outside vendors; works independently for all phases of studies
Qualifications:Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education (from an accredited college or university) and Experience Qualifications
One of the following is required:
- PhD in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years of relevant experience. 1 or more years industry experience required.
- Masters' degree with 6 years of relevant experience. 1 or more years industry experience required.
- Bachelor's degree with 8 years of relevant experience. 1 or more years industry experience required.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
