Director, Pharmacometrics
A
AllucentDrug Development
United Kingdom. Spain. Netherlands. Switzerland. France. ItalyFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 6–10 years of experience in drug development and pharmacometrics
- Required Skills
- R
Requirements
- Life science, healthcare, or business degree.
- Minimum 10 years of relevant work experience in drug development, clinical pharmacology, and pharmacometrics.
- Strong regulatory experience, including regulatory report writing.
- Direct experience with regulatory submissions including INDs, CTAs, regulatory meetings, and NDA/BLA/MAA submissions.
- Proficiency in NONMEM, Pirana, and R software.
- Excellent organizational, negotiating, and financial skills.
- Ability to build relationships and drive results with business acumen.
- Strong strategic thinking and leadership abilities.
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 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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