Associate Director, Clinical Operations – Therapeutics​/Oncology

Responsibilities

• Accountable for delivery of assigned clinical study budget, timelines, and resource management with a 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 phase4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs.
• 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.
• Represent Clinical Operations on cross‑functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures.
• 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.
• Oversee 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 and maintenance of departmental and organizational SOPs to ensure compliance.
• Lead and/or participate in clinical operations work streams related to departmental and operating model initiatives.
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna.
• Support program level deliverables and 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.

• Minimum of a Bachelor’s degree with at least 8–10 years of clinical trial and 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). An advanced degree is preferred.
• Robust experience in oncology is required.
• Experience in early clinical development and immuno‑oncology is desirable.
• Experience in hematologic malignancies is desirable.
• Multi‑dimensional clinical operations background with capability to devise plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, and data cleaning.
• Cross‑collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance and Program Management.
• Experience in GCP inspections and audits.
• Outstanding verbal and written communication skills with excellent organizational skills.
• Proven track record of effective leadership and team‑building skills in a multi‑disciplinary team in the biotech or pharmaceutical industry.
• Resilient, creative, and capable problem‑solving ability.
• Excellent organizational skills and the ability to work independently.
• Experience in establishing and maintaining relationships with key opinion leaders.
• Some travel required.

• Competitive healthcare package plus voluntary benefit programs to support individual needs.
• Holistic well‑being approach with access to fitness, mindfulness and mental health support.
• Famil…