Senior Manager, Preclinical Study Management

Alnylam Pharmaceuticals•Cambridge, MA

2d•$144,800 - $196,000•Hybrid

About The Position

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 hybrid (onsite preferred) and will be primarily located at Cambridge, MA and will require approximately 10% domestic travel with infrequent international travel.

Requirements

B.S. in biology/toxicology or a related field with 8+ years relevant experience in the biotechnology/pharmaceutical industry or contract research organization
Strong attention to detail, with the ability to critically evaluate study-related documentation and correspondence
Knowledge of global regulatory guidelines (ICH/GLP/OECD)
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

Nice To Haves

Ph.D. in a biology/toxicology related field preferred
Previous Study Directorship or Study Coordination at a CRO is highly desired
Previous experience in conducting laboratory animal research studies a plus
Working knowledge of invoicing/accounting/contract management preferred

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 Master Schedule smart sheet 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
Assist with Scientific Site Qualifications
Ability to take on other projects as needed