Alnylam Pharmaceuticals · 10 hours ago
Senior Manager, Preclinical Study Management
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
$139K/yr - $188K/yr
8+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, and they are seeking a Senior Manager for Preclinical Study Management. The candidate will oversee contracted in vivo and in vitro studies, collaborating with internal teams to manage preclinical studies at CROs and ensuring compliance with regulatory guidelines.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Hiring Manager
Jeannine Ripley
Responsibilities
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
Qualification
Required
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
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
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase