Director - DMPK and clinical pharmacology

Natick, MassachusettsPosition closedAllorion Therapeutics is seeking a talented Director or Senior Director to lead the DMPK function and interact with research and development teams to advance Allorion's programs. This position has responsibility to ensure that DMPK assessments for research compounds are conducted to support advancement to development candidates and to progress development candidates to registrations. The Head of DMPK is also responsible for overseeing the preparation of DMPK sections of regulatory submissions and serves on project teams.ResponsibilitiesOversee DMPK activitiesDevelop close and collaborative working relationships across functions especially with toxicology, clinical and pre-clinical pharmacology groupsEnsure adequate DMPK representation on project teams and integration of DMPK insights into clinical programs and alignment of nonclinical DMPK and clinical activities related to drug metabolism and pharmacokineticsCollaborate with research to develop critical pathways to select development candidatesDesign DMPK studies to support clinical trials and product registrationProvide oversight for preparations of DMPK portions of regulatory submissions and clinical documentsInteract with regulatory agencies on drug metabolism and pharmacokinetic issues related to development projectsCritically evaluate project data while rigorously making data-driven Go/No-go decisions, including identification of resource constraints and bottlenecksPromote a group culture of agility, pro-action, collaboration and innovationRequired Skills Ph.D. in a related field10+ years of drug discovery experience in the pharmaceutical industryAbility to work within interdisciplinary teamsCommunication in a clear and concise manner both internally and externallyStrong organizational skills and the ability to manage multiple tasksExperience in preparing regulatory submissions and supportive documentsDemonstration of highly successful project execution across disease areas using in-house and/or CRO resources leading to preclinical candidates for further clinical developmentImpeccable attention to detail, and excellent ability to perform hands on experiments, research/design/organize projects and maintain detailed documentationAble to provide leadership on a cross-functional teamPossess effective verbal, written, and interpersonal communication skillsStrong understanding of the drug discovery process and demonstrated leadership on cross-functional teams