Associate Director, Clinical Ops — Oncology/ImmunoTherapeutics

Moderna Inc.

Cambridge (MA)

On-site

USD 143,000 - 257,000

Full time

3 days ago
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Benefits offered by this job

Healthcare
Well-being programs
Family planning support
Paid time off
Retirement savings
Location-specific perks

Job summary

Moderna is seeking an Associate Director of Clinical Operations to manage and oversee studies within the Oncology/Therapeutics portfolio, including autoimmune and other complex modalities. This role will lead trials across all phases, work with CROs/vendors, and drive cross-functional strategy.

The ideal candidate has strong experience in first-in-human studies and autoimmune or immune-mediated diseases, with the ability to manage budgets, timelines and cross-functional collaborations within a

Qualifications

  • BA/BS with 8–10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management and full trial life cycle experience.
  • Robust Clinical Operations experience in autoimmune, oncology, neuroimmunology, CAR-T/cell therapy, gene therapy or other complex modalities.
  • Cross-functional collaboration with Regulatory, CMC, Biostatistics, Data Management and Finance.
  • Experience in GCP inspections/audits and in leading multi-disciplinary teams.
  • Strong leadership, communication, and problem-solving skills with ability to work independently.

Responsibilities

  • Deliver clinical study budgets, timelines and resources with a focus on quality.
  • Develop operational strategy and Clinical Development Plan execution plans.
  • Lead and oversee first-in-human through phase 4 trials, including CRO/vendor oversight.
  • Communicate study status, costs and issues to senior management for timely decisions.
  • Represent Clinical Operations on cross-functional teams and vendor meetings to ensure SOP compliance.
  • Mentor assigned Clinical Trial Managers and Associates and drive continuous improvement.

Skills

Clinical operations leadership
Trial management
ICH/GCP compliance
Cross-functional collaboration
Budget management
Vendor management
First-in-human experience

Education

BA/BS
Advanced degree preferred

Job description

Moderna is seeking an Associate Director of Clinical Operations to manage and oversee studies within the Oncology/Therapeutics portfolio, including autoimmune and other complex modalities. This role will lead trials across all phases, work with CROs/vendors, and drive cross-functional strategy.

The ideal candidate has strong experience in first-in-human studies and autoimmune or immune-mediated diseases, with the ability to manage budgets, timelines and cross-functional collaborations within a

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