New Director role in Pharmacometrics available. Large company. Remote is okay within the US or can be onsite in the tristate area (NY/NJ/CT). If interested, please let me know. Small and large molecule therapeutics. Therapeutic area somewhat diverse, many project in oncology, CNS, among others. Please email me at brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com> for more info and to discuss.
Responsibilities * Responsible for pharmacometrics strategy on the program level to evaluate risk/benefit and facilitate drug development decisions. Will work in close collaboration with translational science colleagues and other R&D partners and serve as department project lead and representative. * Lead design and implementation of the PMX strategy and other advanced MIDD approaches to enable quantitative decision making thorough the drug development cycles * Manage and perform pharmacometric analyses (both internally and by external CRO vendors) using various tools and approaches * Integrate, interpret, and report results to project teams and upper management! * Proactively contribute into key pre-clinical, clinical, and regulatory documents ; clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and BLA/NDA's within agreed timelines, and meeting all regulatory requirements * Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance) * Qualifications * PhD in clinical Pharmacology/Pharmaceutical sciences/pharmacology/Statistics/engineering with academic training in Pharmacometrics. Ideally 10 years industry or related experience. Use of NONMEM and R is required. * Strong quantitative skills and expertise (e.g. experience in areas such as literature meta-analyses, population modeling, E-R, and clinical trial simulations) mechanistic modeling experience is a plus * Excellent knowledge of drug development process * Communication and presentation skills [image001.png] Brenda Roseberry Vice President, Scientific Recruiting, Carter Mackay Holdings DMPK, Clinical Pharmacology, Pharmacometrics, QSP 315-415-4353 - Mobile
