Associate Director, Clinical Operations

Overview

The Associate Director is responsible for leading a team of Global Trial Leaders and Trial Managers within the Study Management Organization. The position oversees staff development and study execution, collaborating closely with the Director on project assignments, workload distribution, resourcing, and prioritization. The Associate Director influences trial objectives, identifies operational issues across trials and programs, and addresses them through risk mitigation and alternative solutions. They are accountable for the operational execution of all trials within a program.

Key Responsibilities
Ensure delivery of operational strategy aligned with the Clinical Development Plan, business goals, and trial objectives, including resourcing, budget, and change control, in partnership with CTWG and CDST. May chair or support Trial Leaders in leading the CTWG.
Define or align on operational strategies for each trial, securing governance endorsement.
Lead scenario planning and mitigate risks impacting timelines and budgets.
Provide oversight and escalate issues appropriately.
Communicate operational strategies and defend plans and costs at meetings.
Ensure inspection readiness for trials.
Build and develop a knowledgeable, skilled team capable of successful trial setup and delivery.
Promote collaboration across cross-functional teams.
Set goals aligned with company and departmental objectives.
Train staff on procedures and systems.
Foster a high-performing team through growth, performance management, and guidance.
Represent Clinical Operations at CDST for early development programs if needed.
Interface with key internal stakeholders and act as liaison between groups.
Lead or participate in process improvements.
Participate in inspections and audits.
Travel as needed, approximately 10% annually with flexibility.
Qualifications
Bachelor’s degree required.
Experience leading global Phase 1-4 clinical trials in CRO, biotech, or pharma.
Expertise in conducting Phase 3 registrational trials.
Knowledge of pharmaceutical development processes.
Strong decision-making, analytical, and financial skills.
Ability to manage all aspects of trial execution.
Excellent leadership, team management, and communication skills.
Experience leading in matrixed, global environments without direct authority.
Strong organizational, problem-solving, and project management skills.
Experience in novel clinical drug development and applying project management best practices.
Proficiency in MS Office Suite.
Additional Information

Alnylam Pharmaceuticals is an equal opportunity employer committed to diversity and inclusion. We foster an environment where employees can bring their authentic selves and achieve their full potential. Our culture is guided by core values: innovation, openness, urgency, excellence, and commitment to people. We have been recognized globally as a top employer and responsible company.

About Alnylam:

Since 2002, Alnylam has pioneered RNA interference therapeutics, transforming scientific possibilities into medicines that target genetic causes of disease. Our mission is to bring groundbreaking medicines to patients worldwide.

Our culture:

We prioritize an inclusive, innovative, and passionate work environment, supporting our employees' diverse talents and perspectives.
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