Moderna · 1 day ago
Director, Clinical Operations, Therapeutics and Oncology
Cambridge, MA
Full-time
Onsite
Director/Executive
$167K/yr - $301K/yr
10+ years expModerna is seeking a Director of Clinical Operations to manage oncology programs which may consist of one or more studies. This role involves initiating and leading clinical programs across all phases and overseeing CROs and vendors while collaborating with cross-functional teams to ensure successful execution of projects.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
Responsibilities
Accountable for delivery of assigned clinical program 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 Development Lead, Regulatory Lead, and other relevant stakeholders
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
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 and provide oversight to 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
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
Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff
Strive for continuous improvement and more efficient ways of working in clinical development
Act as a role model for Moderna’s values
Qualification
Required
Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management
Robust experience in oncology required
Late-stage/phase 3 experience required
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 therapeutic areas and 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
Preferred
Advanced degree preferred
Experience in immuno-oncology is desirable but not required
Benefits
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, 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 investment opportunities to help you plan for the future
Location-specific perks and extras
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-01-24
legacy.thefly.com
2026-01-23
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