Associate Director, Clinical Operations, Therapeutics and Oncology

Role Summary

Associate Director, Clinical Operations, Therapeutics and Oncology role leading studies within the Oncology Therapeutic Area, overseeing trials across all phases, CROs/vendors, and cross-functional clinical operations strategy to ensure successful execution of development programs.

Responsibilities

• Accountable for delivery of assigned clinical study budget, timelines, and resource management with a focus on quality; make recommendations and decisions regarding operational strategies to support study/program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Partner and collaborate with cross-functional stakeholders (e.g., Project Leader, Clinical Lead)
• Lead and oversee execution of first-in-human through phase 4 trials, per program lifecycle, in compliance with ICH/GCP, local regulations, and Moderna SOPs
• Manage invoice and budget tracking for individual studies; provide input into budget forecasting
• Support the selection, oversight, and management of CROs and other vendors
• Oversee site feasibility/capability assessments with CRO and cross-functional team
• Review and provide clinical operations input into documents such as protocol, investigator brochure, regulatory documents, clinical study reports
• Manage cross-functional team and CRO/vendor activities related to clinical trial operations
• Represent Clinical Operations on cross-functional project teams and vendor/CRO meetings; ensure compliance with standards and procedures
• Represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study-level Sponsor Oversight of outsourced activities
• Communicate study status, cost, and issues to enable timely senior management decisions
• Manage budget tracking for studies and provide input into monthly/annual forecasting
• Oversee/collaborate on inspection readiness activities for audits/regulatory inspections
• Maintain oversight and participate in SOP creation/review/training/maintenance to ensure compliance
• Lead/participate in clinical operations workstreams related to departmental/operating model initiatives
• Develop relationships with key stakeholders within and external to Moderna
• Support program-level deliverables/activities as needed by Senior Director, Clinical Operations
• Provide mentorship to assigned Clinical Trial Managers and Clinical Trial Associates
• Strive for continuous improvement and efficient practices in clinical development
• Act as a role model for Moderna’s values

Qualifications

• Minimum BA/BS with 8–10 years of trial and clinical program experience; at least 4 years independent clinical trial management and full lifecycle experience; advanced degree preferred
• Robust oncology experience; late-stage/Phase 3 leadership and inspection readiness required; immuno-oncology experience desirable but not required
• Multi-dimensional Clinical Operations background with capability to address site activation, enrollment, monitoring oversight, protocol deviations, data cleaning, etc.
• Cross-collaboration proficiency with Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
• Experience in GCP inspections/audits
• Strong verbal/written communication and organizational skills
• Proven leadership and team-building skills in a multi-disciplinary biotech/pharma environment
• Resilient, creative, problem-solver; ability to work independently
• Experience in establishing relationships with key opinion leaders
• Some travel required

Skills

• Leadership and team mentorship
• Budgeting and forecasting
• Operational strategy and planning
• Vendor/CRO management
• Cross-functional collaboration
• Regulatory and quality compliance
• Communication and stakeholder management

Education

• BA/BS required; advanced degree preferred

Additional Requirements

• Some travel may be required