Sr. Pharmacometrician
Allucent, Netherlands
Job Description
CATO SMS and Pharm-Olam, LLC have merged to form Allucent!
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.
We seek a Pharmacometrician for exciting opportunities within our growing firm to work with industry-leading consultants in modeling and simulation. The successful candidate will possess an understanding of pharmacometrics, pharmacokinetics, PK/PD, and modeling concepts and applications. Excellent writing, communication, and mathematical skills are requisite to success in this position.
Responsibilities:
- Direct and/or conduct population PK analysis using appropriate software
- Develop novel population PK analysis approaches the increase the efficiency and accuracy of population PK analysis
- Assist in the 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 advice to clients, develop clinical pharmacology strategic plans, and take ownership/responsibility for client deliverables
- Work with other consultants to prepare and review PK reports and other clinical pharmacology documents
- Author clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
- Represent clients at meetings with US and ex-US regulatory agencies
- Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and execute clinical studies
- Maintain current knowledge of advancements in PK and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal company guidance to be able to contribute ideas to improve technologies and procedures for PK practices
- Support business development and marketing activities, foster client relationships, and bring new clients into the consulting firm
- Maintain up-to-date training on appropriate company SOP's and guidance
Requirements
- M.S. or Ph.D. in pharmacometrics, pharmacokinetics, pharmaceutical sciences, pharmacology, biostatistics, or similar disciplines where modeling and simulation is emphasized
- 4+ years of industry experience in practical applications of modeling and simulation required
- Proficiency in NONMEM, R, and Phoenix (WinNonlin and NLME) preferred
To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes