Oncology Clinical Operations Lead

Moderna Therapeutics; Cambridge (MA); On-site; USD 142,500 - 256,500; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous PTO

Savings & investments

Location-specific perks

Job summary

Moderna is seeking an Associate Director of Clinical Operations in Cambridge to lead oncology trials across multiple phases, oversee CROs and vendors, and drive cross-functional collaboration with clinical development teams.

You will manage study budgets and timelines, contribute to the Clinical Development Plan, ensure GCP compliance, and mentor Clinical Trial Managers within Moderna's in-office model.

Qualifications

• Minimum of BA/BS with 8-10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience.
• Robust experience in oncology required. Experience in early clinical development and immuno-oncology desirable.
• Cross-Collaboration with Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

Responsibilities

• Accountable for delivery of assigned clinical study budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan.
• Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs.
• Support the selection, oversight, and management of CROs and other vendors.
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.

Education

BA/BS degree

Job description

Moderna is seeking an Associate Director of Clinical Operations in Cambridge to lead oncology trials across multiple phases, oversee CROs and vendors, and drive cross-functional collaboration with clinical development teams.

You will manage study budgets and timelines, contribute to the Clinical Development Plan, ensure GCP compliance, and mentor Clinical Trial Managers within Moderna's in-office model.