Senior Manager, Preclinical Study Management

Alnylam Pharmaceuticals

8d • Onsite

About The Position

The candidate will oversee externally contracted in vivo and invitro studies supporting Alnylam’s research portfolio. He or she will collaborate closely with internal research teams to design and manage preclinical studies conducted at Contract Research Organizations (CROs). 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. The candidate will evaluate external capabilities, prepare requests for quotations, assess proposals and cost estimates, manage program timelines, and ensure alignment with the approved investment plan. In addition, the candidate will be responsible for study award, purchase order and invoice management, and maintaining budget forecasts for up to five years.
This position is onsite located in Cambridge, MA an will require approximately 10% 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

• 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

• 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

Benefits

• medical, dental, and vision coverage
• life and disability insurance
• a lifestyle reimbursement program
• flexible spending and health savings accounts and a 401(k)with a generous company match
• paid time off, wellness days, holidays, and two company-wide recharge breaks
• generous family resources and leave

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1,001-5,000 employees