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Senior Manager, Preclinical Study Management

Cambridge, MA

Overview

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 preferably onsite in Cambridge, MA.  Exceptions for hybrid or remote work may be considered for exceptionally qualified candidates, subject to business needs and approval. The position requires approximately 10% 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 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

Qualifications

  • PhD. in a biology/toxicology related field preferred
  • 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

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including 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. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

U.S. Pay Range

$144,800 - $196,000 USD

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