Associate Director Clinical Operations

System One; Waltham (MA); Hybrid; USD 180,000 - 235,000; Full time

Job summary

System One is seeking an Associate Director of Clinical Operations in Waltham, MA. This hybrid role (2 days onsite) requires leadership of trial teams and oversight of global programs in advanced therapies.

You will collaborate with cross-functional teams, sites, and CROs, ensuring high-quality deliverables, regulatory adherence, and efficient budgeting and timelines. A strong background in GCP/ICH and staff development is essential.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years of progressive experience in clinical operations.
• 5+ years in a biopharmaceutical organization.
• Experience overseeing CRO selection, contracting, and management.
• Thorough understanding of GCP and ICH regulations, clinical trial monitoring, and compliance.
• Strong written and verbal communication and cross-functional collaboration.
• Occasional travel up to 5%.

Responsibilities

• Provide leadership and guidance to clinical trial teams supporting advanced therapy initiatives.
• Collaborate with internal teams, sites, and CRO partners to execute global programs safely and compliantly.
• Ensure trials adhere to GCP, regulatory requirements.
• Manage and forecast trial budgets and timelines aligned with company objectives.
• Partner with US/EU/international colleagues, CROs, and investigators to identify risks and plan management.
• Develop study deliverables such as Protocols, CRFs, SAPs, CSRs, and manuals.
• Evaluate KPIs and SOPs; identify gaps and propose improvements for compliance and efficiency.
• Contribute to regulatory filings domestically and internationally.
• Mentor Clinical Operations staff and participate in staffing and performance management.
• Engage with senior management on projects and department initiatives.
• May oversee a team to achieve organizational goals.

Skills

Leadership

Cross-functional collaboration

GCP/ICH knowledge

Clinical operations management

Budget forecasting

Risk management

Data interpretation

Staff development

Education

Bachelor's degree in Life Sciences

Job description

Job Title: Associate Director Clinical Operations
Location: Waltham, Massachusetts
Type: Perm
Work Model: Hybrid – 2 days onsite in Waltham

Leading Pharmaceutical Company located in MA is hiring an Associate Director Clinical Operations with 5+ years industry experience.

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, with at least 5 years in a biopharmaceutical organization
• Experience overseeing CRO selection, contracting, and management
• Thorough understanding of GCP and ICH regulations, clinical trial monitoring, and compliance
• Prior experience in advanced therapies clinical research is desirable
• Strong written and verbal communication skills
• Ability to work cross-departmentally and cross-functionally
• Competent in data management, interpretation, and communication
• Excellent interpersonal, conflict resolution, decision-making, and delegation skills
• Occasional travel (up to 5%)

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.