Associate Director, Clinical Operations - CTA/CTS Management

The Associate Director, Clinical Operations will lead and manage a team of Clinical Trial Associates and Specialists (CTAs and CTSs) responsible for the administrative support of the planning, execution, and close-out of clinical trials across multiple therapeutic areas (TAs). This individual will serve as a strategic and operational leader within Clinical Operations, ensuring adequate resourcing of FTEs and FSPs, cross-TA collaboration, and talent development.

This role requires a strong foundation in clinical trial execution, GCP compliance, resource planning and management, and FSP vendor management.

This position is hybrid and will be primarily located in Cambridge, MA.

Key Responsibilities

Team Leadership & Talent Development

• Directly manage and mentor a team of CTAs and CTSs, fostering a high-performance culture.
• Set team goals and individual development plans aligned with EA and corporate objectives.
• Provide coaching, performance feedback, and support career progression.
• Assess, plan and manage resourcing, and alignment across clinical programs.
• Idenitify training needs for CTA/ CTS roles and create and implement onboarding plan.
• Establish strong relationship with FSP provider to manage resource availability, create accurate resource forecasting, with the ability to scale up and down according to study needs.
• Create a positive culture, imbedding CTA/CTS in Alnylam culture and values, and maintaining low turn-over rates.

Operational Oversight

• Ensure high-quality CTA/CTS support for trial start-up, conduct, and close-out activities.
• Oversee teams' activities related to trial master file (TMF) documentation, meeting management (scheduling, agendas, minutes, and tracking of action items), site communication tracking, and vendor coordination.
• Manage FTE resources and FSP contract and invoicing for the CTA/ CTS work, forecasting spend through LRP/ IP and tracking variance and communicating with study leads if additional spend is required
• Monitor compliance with SOPs, GCP, and regulatory requirements.
• Identify and implement process improvements to drive consistency and efficiency in CTA/CTS resourcing and activities.

Cross-functional Collaboration

• Partner closely with Global Trial Leads, Managers, and other stakeholders to align on trial priorities and operational needs.
• Serve as a key point of escalation for CTA/CTS-related issues, assist with problem identification and solving.
• Contribute to yearly Long-Range Planning (LRP), Investment Planning (IP), and forecasting of resource needs.

Process, Quality & Metrics

• Develop and refine CTA/CTS work practices, tools, and SOPs.
• Track and report on CTA/CTS performance metrics and KPIs.
• Lead or contribute to internal audits and inspection readiness initiatives related to CTA/CTS activities.

Qualifications

• Bachelor's degree in life sciences, nursing, or related field (advanced degree preferred).
• 7+ years of experience in clinical research, with at least 3 years in line-management role.
• Prior experience overseeing CTA/CTS teams or operational support staff strongly preferred.
• Deep understanding of ICH-GCP, clinical trial phases, and regulatory frameworks.
• Demonstrated leadership, interpersonal, and problem-solving skills.
• Strong organizational and communication skills.
• Experience in a matrixed or global environment.
• Proficiency with CTMS, eTMF, and other clinical systems.
• Passion for team development and operational excellence.
• Ability to thrive in a fast-paced, dynamic environment.

U.S. Pay Range

$166,700.00 - $225,500.00

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 a number of factors including, but not limited to, 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).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach 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 possibleand 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. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.