Associate Director, Pharmacometrics
New
A
AllucentClinical Pharmacology
United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 6–10 years
- Required Skills
- R
Requirements
- 6–10 years of relevant work experience in drug development, clinical pharmacology, and pharmacometrics
- Life science, healthcare, or business degree
- Regulatory experience including regulatory report writing
- Experience with regulatory submissions including INDs, CTAs, and NDA/BLA/MAA submissions
- Proficiency in NONMEM, Pirana, and R software
- Excellent organizational, negotiating, and financial skills
- Proven analytical thinking and business acumen
Responsibilities
- Lead and conduct population PK analyses using advanced modeling tools and methodologies
- Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
- Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.)
- Provide guidance to optimize pharmacokinetic sampling and dosing strategies
- Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
- Author and review PK reports and clinical pharmacology sections of regulatory documents
- Represent clients in regulatory interactions and contribute to business development and relationship management
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