Senior Manager, Preclinical Study Management

Job description

Overview The candidate will be responsible for overseeing externally contracted in vivo and in vitro studies supporting both research and early development programs. This role will collaborate closely with internal research and development teams to design, manage, track, and report preclinical studies conducted at external Contract Research Organizations (CROs). The candidate will work directly with study teams to develop and/or obtain accurate study designs, assess external capabilities, and prepare requests for quotations (RFQs) for qualified laboratories. Responsibilities include evaluating and comparing proposals, cost estimates, and timelines, and ensuring compliance with the approved investment plan. The candidate will support funding applications and award studies to qualified laboratories, securing appropriate resources and timelines. Additional responsibilities include supporting protocol development, monitoring study conduct, and ensuring accurate and timely reporting of study results. The candidate will ensure all study materials and data are properly archived within Alnylam systems. The role will also be responsible for maintaining current and long-range budget projections, with ownership of financial forecasting for up to five years. The successful candidate thrives in a fast-paced, high-volume environment by multitasking effectively prioritizing urgent tasks, and maintaining high quality standards under tight deadlines.   This position is preferably onsite in Cambridge, MA.  Exceptions for hybrid or remote work may be considered for exceptionally qualified candidates, subject to business needs and approval. The position requires approximately 10% domestic travel, with infrequent international travel. Key Responsibilities • Generate and Submit Concept Sheets to Contract Research Organizations (CROs) and obtain competitive bids and timelines and negotiate as appropriate • Work closely with other functional areas (including Toxicology, DMPK, Bioanalysis, Biology, Pathology, CMC, Program Management, Accounting, Legal, Procurement, Supply Chain, Sample Management) in order to facilitate planning, development, tracking, and study timelines of nonclinical outsourced studies • Generate SOWs and review and process CRO contracts • Assist Research and Early Development personnel in preparation for CRO studies (e.g. protocol development, animal orders, test article projections, and shipments) • Assist investigators with preparation, review and circulation of study documents including protocols and amendments • Maintain complete, organized, and current study files including study schedules, contracts, protocols, and other applicable documents and correspondence • Interface effectively with technical writing group and other Alnylam personnel to manage/track internal report and sub-report timelines and status • Provide administrative support for contracted non-clinical studies • Interface effectively with CMC and Supply Chain to manage test article supplies and orders • Interface effectively with CROs and Analytical Chemistry to assure GLP-compliant test article characterization and stability and retests • Conduct CRO site visits for study monitoring at key study milestones • Participate in regular teleconferences with CROs including but not limited to: pre-study meetings, bi-weekly/monthly CRO program meetings, operational, and pre-reporting ("tox/path") meetings • Interface effectively with Business Planning & Program Management and Accounting/Finance departments to assist with accurate investment plan forecasting, award contracts and to review and process invoices for payment • Interact cross functionally within the Research and Early Development group, with project teams, as well as across other drug development expertise areas • Manage outsourcing of preclinical studies (GLP and non-GLP) for inclusion in Regulatory submissions, including pharmacokinetic, toxicology, and biodistribution studies • Work within established contract research organization agreement terms to support preclinical development programs • Act as primary contact and provide oversight to CRO partners to ensure consistent practices across vendors, groups and sites, communicate and trouble-shoot issues and track/forecast activities • Participate in selection of CROs including qualification/scientific assessments and tracking vendor performance • Helps manage the Maste