Lead Clinical Operations for Oncology Trials

Moderna; Cambridge (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare

Generous paid time off

Location-specific perks

Job summary

Moderna seeks an Associate Director of Clinical Operations to lead studies in the Therapeutics/Oncology space, directing trials across all phases and overseeing CROs and vendors. You will work with cross-functional partners to develop operational strategies and ensure successful execution of development programs.

You will manage budgets, timelines, and resource allocation, contribute to study documentation and regulatory submissions, and mentor Clinical Trial Managers and Associates while

Qualifications

• BA/BS with 8–10 years of trial and clinical program experience; advanced degree preferred.
• Robust experience in therapeutics/oncology; early development and immuno-oncology desirable.
• Multi-dimensional Clinical Operations background for site activation, enrollment, monitoring, etc.
• Cross-collaboration with Regulatory, CMC, Biostatistics, Data Management, Finance, PM.
• Experience in GCP inspections/audits.
• Strong communication and organizational skills; demonstrated leadership within a multi-disciplinary team.

Responsibilities

• Deliver study budgets, timelines, and resources with a focus on quality.
• Develop operational strategy in support of the Clinical Development Plan.
• Lead end-to-end trials from first-in-human through phase 4, in compliance with SOPs.
• Oversee CROs and vendors; manage site feasibility and capabilities.
• Review documents (protocol, ICF, regulatory documents) for input from Clinical Operations.
• Represent Clinical Operations on cross-functional teams and external interactions.

Skills

Trial management

Cross-functional collaboration

Budget management

Leadership & mentoring

ICH/GCP compliance

Vendor/CRO oversight

Education

BA/BS in life sciences

Advanced degree preferred

Tools

CTMS

Budget tracking software

Job description

Moderna seeks an Associate Director of Clinical Operations to lead studies in the Therapeutics/Oncology space, directing trials across all phases and overseeing CROs and vendors. You will work with cross-functional partners to develop operational strategies and ensure successful execution of development programs.

You will manage budgets, timelines, and resource allocation, contribute to study documentation and regulatory submissions, and mentor Clinical Trial Managers and Associates while