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 workstreams 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. Basic Qualifications 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. Pay & Benefits Competitive healthcare package plus voluntary benefit programs to support individual needs. Holistic well‑being approach with access to fitness, mindfulness and mental health support. Family planning benefits, including fertility, adoption and surrogacy support. Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days and a discretionary year‑end shutdown. Savings and investments to help plan for the future. Location‑specific perks and extras. Salary range: $142,500.00 – $256,500.00. The position’s placement in the range depends on competencies, experience, performance and business needs. Eligible for an annual discretionary bonus, other incentive compensation or equity award, subject to company plan eligibility and individual performance. EEO Statement Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E‑Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process or to perform the essential functions of the position should contact the Accommodations team. #J-18808-Ljbffr Moderna Therapeutics