Senior/Executive Director, Biotransformation and Drug-Drug Interaction
: Job Details :

Senior/Executive Director, Biotransformation and Drug-Drug Interaction Massachusetts - HybridJoin our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.COMPANY OVERVIEW:Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.POSITION OVERVIEW:The Early Development and Clinical Pharmacology (EDCP) group at Disc Medicine seeks a scientific expert in biotransformation and drug-drug interaction (DDI) evaluation areas. The successful candidate will provide biotransformation and DDI evaluation strategy and execution to support drug discovery, nonclinical development, and clinical development. This includes designing in vitro metabolic enzyme and transporter-related studies, drug-drug interaction risk evaluation, and clinical DDI evaluations via clinical studies and/or PBPK modeling. This person is expected to interact with cross-functional teams providing biotransformation, DDI evaluation, and other scientific inputs. The successful candidate will also provide biotransformation-related strategy and support to achieve program milestones, including IND, IB, and NDA submissions. The candidate should have expertise in biotransformation, transporter, and drug-drug interaction areas and comprehensive knowledge of best regulatory practices and experimental methodology.RESPONSIBILITIES:Provide biotransformation and DDI evaluation to enable internal decisions and regulatory filings.Manage outsourced biotransformation, transporter, and DDI work to ensure high-quality deliverables of in vitro and in vivo studies.Represent EDCP at regulatory meetings and respond to regulatory inquiries related to biotransformation, transporter, and DDI.Provide biotransformation and DDI support for regulatory summary documents.Provide effective biotransformation and DDI assessment and strategy to address project-related issues, including drug exposure, toxicology, clinical pharmacology, and regulatory-related issues.REQUIREMENTS:PhD. with +12 years of experience in biotransformation, transporter, and DDI evaluation in the pharmaceutical industry.Demonstrated expertise in biotransformation, transporter, and DDI areas; familiar with FDA's guidance on DDI evaluations and comprehensive knowledge of quantitative DDI risk assessment.Experience writing and presenting biotransformation and DDI results to regulatory authorities supporting IND and NDA/MAA applications.Track record of scientific excellence in biotransformation and DDI assessment, evidenced by publication in scientific journals and/or presentation at scientific conferences.Excellent interpersonal, organizational, and communication skills. Experience in cross-functional interactions in matrix teams.PREFERRED QUALIFICATIONS:Broad experience in drug development supporting early and late-stage drug discovery and development.Experience in working with CROs.Using SimCYP in DDI evaluations.Design and execution of isotope-ADME studies in animals and humans.Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.#J-18808-Ljbffr