Senior Manager Clinical Operations jobs in United States
cer-icon
Apply on Employer Site
company-logo

Alnylam Pharmaceuticals · 16 hours ago

Senior Manager Clinical Operations

positionCambridge, MA
timeFull-time
remoteOnsite
senioritySenior Level
date7+ years exp

Alnylam Pharmaceuticals is a company focused on delivering innovative therapies. The Sr. Manager, Clinical Operations is responsible for the end-to-end clinical trial delivery, leading a cross-functional trial team, and ensuring trials are delivered on time, within budget, and compliant with regulations.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
check
Comp. & Benefits
check
H1B Sponsor Likelynote
Hiring Manager
Adam Lentz, MBA
linkedin

Responsibilities

Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution
Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/ CSR/ TLR planning and scope, define protocol deviations and resolution pathways)
Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
Identify risks and ensure mitigations and contingencies are being initiated and followed through
Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
Participate in process improvement activities at a trial and department level as needed
Mentor & support onboarding of new team members, particularly those in Study Management
Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups
Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure
Support and provide input into internal governance presentations & updates
Ability to travel approximately 10% but flexibility to go over or below as per business need)

Qualification

Clinical research experienceGlobal clinical trials managementFinancial management skillsProject planning/managementLeadership skillsCommunication skillsMS Office Suite proficiencyMentoring/coachingOrganizational skillsProblem-solving abilityPresentation skills

Required

BS/ BA degree is required
Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials
3-5 years leading end to end global clinical trials with experience in conducting Phase 3 registrational trials
Experience leading global trials outsourced to a CRO and ability to manage all aspects of execution of a clinical trial
Excellent decision-making, analytical and financial management skills are essential to this position
Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
Experience in leading without authority and in multifunctional matrixed and global environments
Experience mentoring/ coaching others
Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability
Strong project planning/ management, communication (written and verbal) and presentation skills
Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project

Company

Alnylam Pharmaceuticals

twittertwittertwitter
Glassdoor3.8
company-logo
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
dateFounded in 2002
location
Cambridge, Massachusetts, USA
people-size1001-5000 employees
web-link
http://www.alnylam.com

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 Company
Total Funding
$4.55B
Key Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO

Leadership Team

leader-logo
Yvonne Greenstreet
Chief Executive Officer
linkedin
leader-logo
Jeff Poulton
Chief Financial Officer
linkedin

Recent News

Boston Globe
As it charts a growth strategy, Alnylam looks to former Vertex executive Stuart Arbuckle for expertise
2025-12-24
MarketScreener
Alnylam Pharmaceuticals, Inc.(NasdaqGS:ALNY) added to NASDAQ-100 Index
2025-12-22
Pharma Letter
Demand prompts Alnylam’s $250 million manufacturing expansion
2025-12-20
Company data provided by crunchbase