Senior Scientist, DMPK- Preclinical Development (2008019)

Description




This position will be responsible for the development and oversight of Acceleron's Discovery and Preclinical Development DMPK function in a manner that conforms to established industry standards and relevant regulatory guidelines. The position will report to the Director of Preclinical Safety.


Job Responsibilities:  


Design, interpret, and report pharmacokinetic studies and toxicokinetic components of toxicology studies in animals in support of preclinical and clinical development Guide clinical team members in selection of dose, dose formulation, route of administration and dose frequency in Phase I clinical study design Actively participate in interdisciplinary project teams dedicated to planning and execution of INDs and other regulatory submissions Peer review reports and regulatory submissions for GLP compliance, completeness and scientific merit Interact with Quality Assurance to schedule and resolve audits Create and modify standard operating procedures as needed Create and modify laboratory methods as needed Develop organizational growth and outsourcing strategies for DMPK function
Required Experience



Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related discipline with at least 5 years of industry and/or related DMPK experience. Prior experience in the development of biotherapeutics is preferred. The candidate should have the following:Extensive knowledge of pharmacokinetic and pharmacodynamic principles An overall understanding of drug research and development A thorough knowledge of preclinical and clinical pharmacology Project team experience representing the preclinical DMPK function Working familiarity with Good Laboratory Practice (GLP) Regulations Experience in preparation of regulatory submissions and interaction with regulatory authorities on preclinical and clinical DMPK issues An overall understanding of small molecule and biotherapeutic method validation, bioanalytical sample analysis, and various instrumentations (HPLC, LC/MS/MS, GC, ELISA, Biacore, etc.) Experience with analytical software such as WinNonlin, NONMEM, or similar programs Experience monitoring bioanalytical studies at CROs Basic understanding of principles of toxicology, molecular biology, and immunology.