Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Description of duties: As a DMPK representative, he/she will be responsible for influencing discovery efforts with respect to metabolism, including guiding medicinal chemistry efforts to advance drug development in neuroscience. The incumbent will be further expected to synthesize the DMPK knowledge of lead candidates and influence the preclinical project plans thereto related. As such, the DMPK Scientist will provides leadership and strategic direction from idea inception through NDA submission. He/she will works with bioanalytical and in vitro pharmacology scientists, internally or externally, to ensure the appropriate experimental plans and data generation in support of optimized compounds. It is highly desired that you will have extensive experience in applying high-resolution mass spectrometry to characterize metabolites and assess metabolic stability in various cellular and subcellular in vitro test systems. The candidate should be able to review and translate complex LC-MS based metabolism data sets and articulate findings to project teams. This role may liaise with the biomarker scientists, PK/PD modelers and project partners to develop the translational pharmacology plan, PK predictions and dose projections for small molecule or biologic therapeutics. The candidate will also partner with other team representatives to advance the ADME science and strategies for prosecuting small molecule projects and may also influence external scientific community through publication and other interactions.
Requirements: Ph.D. (5-10 yrs)or MS/BS (10+ years) in Analytical Chemistry, Chemistry or Chemical Biology with relevant industrial experience in biotransformation and metabolite identification and a strong record of scientific achievement & project influence. In-depth understanding of drug metabolism, enzymology, bioactivation, and physical organic chemistry, with demonstrated ability to utilize scientific results to influence medicinal chemistry efforts. Demonstrated skills and proficiency in all aspects of nominal and high resolution mass spectrometry for metabolite profiling and identification (eg, fluent understanding in the operation and maintenance of a variety of LC-MS/MS instrumentation including Waters QTOF and Thermo Orbitrap based systems); strong computer skills and experience with software driven metabolite profiling is required. Demonstrated ability to integrate data from multiple sources in to a rational understanding of drug disposition; broad understanding of transporter assays desired. Proficiency in human PK predictions.
Experience integrating DM/PK discipline knowledge into both discovery and development teams to help guide decisions. Demonstrated management of contract research organizations and collaborations is required. Experience in drug discovery / development up to POC required; experience in the preparation of regulatory applications (IND, NDA or BLA) and good knowledge of regulatory guidelines is highly desirable. General understanding of drug discovery, chemistry and pharmacology within neuroscience preferred. Individuals with having first-author, peer reviewed publications and/or presentations will be strong candidates for this role.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.