Senior Manager, Preclinical Study Management

Overview

The candidate will be responsible for the oversight of externally contracted invivo and invitro studies for both research and early development programs.  He or she will work directly with study teams to obtain accurate study designs, assess external capabilities, and provide request for quotations to applicable laboratories, evaluate (and compare if applicable) proposals/quotes, timelines and compliance with the investment plan.  Apply for funding and award to a qualified lab securing resources and timing.  Support the study team in protocol development, monitoring conduct and accurately reporting the study. Ensure all applicable study materials are properly archived within Alnylam.  Candidate will be responsible for current budget projections up to 5 years.    

This position is onsite and will be primarily located at Cambridge, MA and will require approximately 20% 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 SOW’s 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 statusProvide 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 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

Qualifications

• 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

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.