Associate Director, Study Management

About the role

This is a hybrid role preferably based in Cambridge, MA or Philadelphia, PA. However, for exceptional candidates, remote working arrangements may also be considered.

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.
• Develop and execute trial operational strategies for assigned studies and contribute to broader program-level planning in partnership with the Director and cross-functional stakeholders.
• 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.
• Effectively communicate the operational strategy and defend the operational plan and costs associated with CTWG, CDST, Director, leadership, and at governance meetings as appropriate.
• Lead and ensure inspection readiness for the trial/s.
• Build a knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials.
• Promote strong collaboration across cross-functional teams.
• Set 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.
• Travel as required (expected annual average of 10% but flexibility to go over or below this as needed).

Requirements

• 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, at least 3 of which leading end-to-end global clinical trials with experience in conducting Phase 3 registrational trials.
• Minimum 2-5 years of direct people leadership experience, including coaching, performance management, and development of clinical operations professionals.
• Experience in and knowledge of the pharmaceutical development process.
• Excellent decision-making, analytical, and strong financial management skills.
• Ability to manage all aspects of execution of a clinical trial.
• 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.
• Exceptional organizational skills and ability to deal with competing priorities, 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.

Pay

U.S. Pay Range $172,600.00 - $233,400.00. The pay range 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 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).

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• Lifestyle reimbursement program.
• Flexible spending and health savings accounts.
• 401(k) with a generous company match.
• Paid time off, wellness days, holidays, and two company-wide recharge breaks.
• Generous family resources and leave.

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.