Senior Manager, Preclinical Study Management

Responsibilities include study design and protocol development, monitoring study execution, accurate data reporting, results presentation, and ensuring all study materials are properly archived in Alnylam's repository. Invivo and invitro study design 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, Program Management, Accounting, Legal, Procurement, Supply Chain, Sample Management) in order to facilitate planning, development, tracking, and study timelines of nonclinical outsourced studies Review SOW's and process CRO contracts Assist research personnel in preparation for CRO studies (e.g. protocol development, animal orders, test article projections, and shipments) 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 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 monitoroing at key study milestones (as applicable) 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 CRO 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 Master Schedule for both internal and external preclinical studies using an in-house preclinical study database Helps facilitate meetings regarding study coordination between groups to align resources and workloads Assist with process improvement initiatives Ensure compliance with global pre-clinical studies regulatory guidelines Ability to take on other projects as needed B.S. in biology/toxicology or a related field with 8+ years relevant experience in the biotechnology/pharmaceutical industry or contract research organization Previous Study Directorship or Study Coordination at a CRO is highly desired Strong attention to detail, with the ability to critically evaluate study-related documentation and correspondence Knowledge of global regulatory guidelines (ICH/GLP/OECD) Previous experience in conducting laboratory animal research studies a plus Working knowledge of invoicing/accounting/contract management preferred Demonstrated organizational and multi-tasking skills and effective time/program management Proficient in Smart Sheets Outstanding communicator responsible for conveying key messages to internal stakeholders and external vendors Ability to navigate and be successful in a fast-paced, highly-networked and program team driven environment with frequent course corrections and changing deliverables and timelines