Alnylam Pharmaceuticals · 17 hours ago
Associate Director Clinical Operations
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expAlnylam Pharmaceuticals is seeking an Associate Director of Clinical Operations to lead a team of Global Trial Leaders and Trial Managers. The role involves overseeing clinical trials, ensuring operational strategies align with business goals, and fostering collaboration across various departments.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Hiring Manager
Adam Lentz, MBA
Responsibilities
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) by partnering with CTWG and CDST on timeline creation
May Chair and/or support the Trial Leader in leading the CTWG for the successful execution of assigned trial/s
Define (for early development), or work with the Director to align on, the Operational Strategy for each trial in the program and gain governance endorsement on proposed plans
Lead operational scenario planning and mitigate trial level risks that may impact timelines / budget
Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership
Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CTWG, CDST, Director, leadership and at governance meetings as appropriate
Lead and ensure inspection readiness for the trial/s
Build knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials
Promote strong collaboration across cross-functional teams
Setting goals in alignment with company, program, and departmental goals
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
For early development programs, AD may represent Clinical Operations at CDST
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
Lead or participate in process improvement activities at a trial and department level as needed
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
Ability to travel (expected annual average of 10% but flexibility to go over or below this as required)
Qualification
Required
BS/ BA degree is required
Minimum 8+ 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 in and knowledge of the pharmaceutical development process
Excellent decision-making, analytical and strong financial management skills are essential to this position
Ability to manage all aspects of execution of a clinical trial
Must possess 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
Strong project planning/ management, communication (written and verbal) and presentation skills
Minimum 2+ years prior line management experience or 3+ years matrixed leadership experience required
Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability
Apply project management best practices to programs. Experience in novel clinical drug development
Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
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
2025-12-22
2025-12-20
Company data provided by crunchbase