Associate Director/Director, Pharmacometrician
A
AllucentDrug development
Workable locations: United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 6–10 years of experience
- Required Skills
- R
Requirements
- Minimum 6-10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
- Sharp analytical thinking
- Expertise in tools like NONMEM, Pirana, and R
- Client-focused and a natural leader who thrives in fast-paced environments
- Strategic thinking, strong communication, and business acumen
- Life science, healthcare and/or business degree
- Regulatory experience including regulatory report writing essential
- Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions
- Proficiency in NONMEM, Pirana, and R software preferred
- Excellent organizational, negotiating and financial skills
Responsibilities
- Lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment.
- Guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones.
- Represent clients in interactions with regulatory agencies.
- 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.) and 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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