Associate Director, Study Start Up

Alnylam Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 170,000 - 210,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking an Associate Director, Study Start-Up to lead end-to-end SSU activities for studies, ensuring timely site activation and regulatory compliance. This role partners across Clinical Operations, Regulatory, Legal, and CROs to identify risks and drive on-time delivery.

The ideal candidate will bring 8+ years in global clinical trial operations with strong leadership, data-driven problem solving, and a deep knowledge of ICH-GCP guidelines.

Qualifications

• Bachelor’s degree in a healthcare, life sciences, or scientific discipline.
• Minimum of 8 years of experience in global clinical trial operations and/or study start-up.
• Minimum of 5 years of people leadership experience, including coaching, performance management, and development of direct reports.
• Strong understanding of global study start-up processes, regulatory pathways, and site activation models.
• Demonstrated ability to manage multiple priorities and deliver results in a matrixed environment.

Responsibilities

• Lead end-to-end study start-up activities including site feasibility, site selection, regulatory submissions, site contracting, and site activation.
• Drive early planning, risk identification, and issue management to support timelines.
• Escalation point for study-level start-up issues with cross-functional partners.
• May provide people leadership for SSU Managers or SSU Leads.
• Ensure consistent application of SSU SOPs, tools, and templates.
• Contribute to development and rollout of SSU processes, tools, and training.
• Drive standardization and best-practice adoption across studies and regions.
• Monitor study-level SSU metrics and KPIs such as activation timelines.
• Use data to identify risks and opportunities for improvement.
• Maintain country and site intelligence to support planning.
• Partner with leadership, feasibility, clinical ops, regulatory, and CROs for alignment.
• Provide oversight of CRO performance related to study start-up.
• Support inspection readiness and compliance with ICH-GCP and regulatory policies.
• Participate in continuous improvement initiatives.

Skills

Study Start-Up

Global Operations

People Leadership

ICH-GCP

Cross-functional Collaboration

Education

Bachelor’s degree in healthcare or life sciences

Job description

Alnylam Pharmaceuticals is seeking a Associate Director, Study Start-up to join our dynamic and growing team.

The Associate Director, Study Start-Up (SSU) provides tactical and operational leadership for assigned studies or programs, with accountability for delivery of end-to-end study start-up activities. This role drives start-up execution, ensures consistent application of SSU processes, and partners cross-functionally to proactively identify risks, resolve issues, and deliver predictable site activation timelines

The Associate Director supports implementation of SSU strategy and process standards while identifying risks, driving issue resolution, and contributing to continuous improvement initiatives.

Key Responsibilities

• Lead execution of end-to-end study start-up activities for assigned studies, including site feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation.


• Drive early planning, risk identification, and proactive issue management to support delivery of study start-up timelines.


• Serve as escalation point for study-level start-up issues, ensuring timely resolution in partnership with cross-functional stakeholders.


• May provide people leadership for Study Start-Up Managers or SSU Leads, as needed.


• Ensure consistent application of SSU SOPs, work instructions, job aids, tools, and templates across assigned studies.


• Contribute to development, refinement, and rollout of SSU processes, tools, and training materials.


• Drive standardization and best-practice adoption across studies and regions.


• Monitor and report study-level SSU metrics and KPIs (e.g., site activation timelines, readiness-to-enroll).


• Use data and insights to identify risks, trends, and opportunities for improvement, escalating as appropriate.


• Ensure accurate maintenance and use of country and site intelligence to support study planning and execution.


• Partner with Study Start-up Leadership, Feasibility, Clinical Operations, Clinical Development, Regulatory, Legal, Finance, and CROs to ensure alignment and timely execution of start-up activities.


• Provide oversight of CRO performance related to study-level start-up deliverables.


• Support inspection readiness and ensure study start-up activities comply with ICH-GCP, global regulatory requirements, and internal policies and procedures.


• Participate in continuous improvement initiatives to improve efficiency, quality, and predictability of study start-up.

Qualifications

• Bachelor’s degree in a healthcare, life sciences, or scientific discipline.


• Minimum of 8 years of experience in global clinical trial operations and/or study start-up.


• Minimum of 5 years of people leadership experience, including coaching, performance management, and development of direct reports.


• Strong understanding of global study start-up processes, regulatory pathways, and site activation models.


• Demonstrated ability to manage multiple priorities and deliver results in a matrixed environment.


• Strong analytical, problem-solving, and communication skills.


• Proven ability to partner cross-functionally and influence without authority.


• Working knowledge of ICH-GCP and the global regulatory environment.


• Experience leading complex, multi-regional studies.


• Experience contributing to process improvement, transformation, or optimization initiatives.


• Demonstrated success leading and retaining high-performing team members

About Alnylam

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.

Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.