Alnylam Pharmaceuticals · 4 hours ago
Director, Clinical Operations
Cambridge, MA
Full-time
Onsite
Director/Executive
$197K/yr - $266K/yr
10+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, committed to transforming the lives of people with rare and common diseases. The Director of Clinical Operations is responsible for the operational execution of the Clinical Development Plan, leading a team to develop program-level strategies, ensure cross-functional alignment, and manage program-level risks.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Responsible for the development of the program-level operational strategy and ensuring alignment across functions, e.g., E2E connectivity across functions, share lessons learned for program-level consistency, and monitor KPIs to track program-level success)
Accountable for the delivery of the operational strategy in alignment with the Clinical Development Plan, ensuring alignment with the business goals and trial delivery objectives (including resourcing, budget, and change control, partnering with CDST sub-teams, timeline creation)
Accountable for representing assigned programs at cross-functional and executive governance forums, presenting operational strategy, risks, and trade-offs, and driving timely, data-informed decisions to enable successful program execution. Attend CDST and function as a strategic partner with program management for the execution across all trials in the program. Attend Leadership Team meetings as required/ requested to provide study updates or as a back-up for senior GTSO leaders
Lead operational scenario planning and mitigate program level risk that may Impact timelines/ budget, ensure appropriate quality oversight, and appropriately escalate Issues to CDST, Quality and functional leadership
Ability to effectively communicate the operational strategy and defend the operational plan and costs associated to CDST, leadership and at governance meetings as appropriate
Lead and ensure inspection readiness for the program
Provide leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues
Provide operational leadership and support to the Associate Directors
Build a knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials
Oversee resource allocation
Promote strong collaboration across cross-functional teams
Setting objectives in alignment with company, program, and departmental objectives
Ensure Staff training on procedures and systems associated with their roles
Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance
Effectively discusses and presents study data across the Company and with development partners; collaborates with clinical development and scientists, medical writers, and investigators to write, present and/or publish data
Participates in, reviews, and provides direction on CRO and vendor outsourcing strategy, and key performance indicators (KPIs) ensuring vendor/ CRO partners consistently deliver high quality data to support regulatory requirements
High Engagement with Peer group to ensure lessons learned and best practice sharing across TAs
Qualification
Required
BSc/ BA degree required
Minimum 10+ years previous experience gained with a CRO and/or biopharmaceutical company
Minimum 5+ years prior line management experience or 5 years matrixed leadership experience required
Ability to travel 10-15%
Must have experience leading/managing externally outsourced, cross-functional teams
Experience in and knowledge of the pharmaceutical development process
Clinical Research operational knowledge and deep experience across multiple phases of studies (1-4)
Must have the ability to manage all aspects of execution of a clinical trial
Excellent decision-making, analytical and strong financial management skills are essential to this position
Strong project planning/management, communication and presentation skills
Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness
Experience leading without authority and in multifunctional matrixed and global environments
Operate and execute with limited supervision
Willingness and proven ability to work flexibly, stepping outside of immediate role responsibilities and wearing multiple hats where needed
Confident and has the professional competence to win respect and gain credibility at all levels within and outside the Company, and capable of successfully representing the Company externally
Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems
Preferred
Advanced degree 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