Associate Director Clinical Operations

Job Title: Associate Director Clinical Operations
Location: Waltham, Massachusetts
Type: Permanent
Work Model: Hybrid – onsite and remote

This Associate Director, Clinical Operations role is a key leadership position supporting innovative advanced-therapy clinical trials (oncology), helping teams deliver studies safely, ethically, and in full compliance with ICH-GCP and applicable regulations. The position partners closely with cross-functional stakeholders, clinical sites, and CROs to execute global programs, proactively manage risk, and ensure high-quality study deliverables. You will also drive alignment on trial budgets, timelines, and performance indicators while contributing to regulatory filings and continuous process improvement.

Responsibilities

• Provide leadership and guidance to clinical trial teams supporting innovative advanced therapy clinical trials.
• Collaborate with internal cross-functional teams, clinical sites, and CRO partners to execute global clinical programs in a safe, ethical, and compliant manner.
• Ensure trials adhere to ICH GCP, federal, international, and local regulatory requirements.
• Manage and forecast trial budgets and timelines, ensuring alignment with company objectives.
• Partner with US, EU, and international colleagues, CROs, and investigators to identify risks and develop effective trial plans.
• Develop high-quality study deliverables such as Protocols, CRFs, SAPs, CSRs, and manuals.
• Evaluate KPIs, KRIs, and SOPs; identify gaps and propose solutions for compliance and efficiency.
• Contribute to regulatory filings domestically and internationally.
• Mentor and develop Clinical Operations team members, participating in staffing, performance management, and talent development.
• Interact regularly with senior management on project and departmental initiatives.
• May oversee a team to achieve organizational goals.

Requirements

• Bachelor’s Degree in Life Sciences or related field
• 10+ years of progressive experience in clinical operations within Oncology, with at least 5 years in a biopharmaceutical organization
• Experience overseeing CRO selection, contracting, and management

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical