Job Title: Associate Director Clinical Operations
Location: Waltham, Massachusetts
Type: Perm
Work Model: Hybrid - onsite and remote
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%)
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Ref: #568-Clinical
