Associate Director, Clinical Operations – Oncology/Therapeutics

Here’s What You’ll Need (Basic Qualifications)

• Minimum of BA/BS with at least 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 (e.g., start-up, conduct, closure). Advanced degree preferred.
• Robust Clinical Operations experience in one or more relevant therapeutic areas or complex modalities required, including autoimmune disease, oncology, neuroimmunology/multiple sclerosis, CAR-T/cell therapy, gene therapy, or another complex therapeutic modality.
• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
• Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
• Experience in GCP inspections/audits
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
• Resilient, Creative, capable problem-solver
• Excellent organizational skills and ability to work independently

• Experience in establishing and maintaining relationships with key opinion leaders
• Some travel required

Here’s What You’ll Do

• 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
• Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders
• 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, with particular emphasis on the operational complexities associated with early clinical development, first-in-human studies and autoimmune studies.
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
• 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
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs
• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna
• Support program level deliverables/activities at the discretion of the Senior Director, Clinical Operations
• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise
• Strive for continuous improvement and more efficient ways of working in clinical development
• Act as a role model for Moderna’s values