Associate Director, Clinical Operations

The Role:

Moderna is seeking an Associate Director Clinical Operations to manage studies within the Clinical Operations Therapeutics and Oncology Therapeutic Area. This position will be responsible for initiating and leading clinical trials across all phases including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position will work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position will be focused on ongoing studies in metabolic rare diseases but the role will later support oncology.

Heres What Youll 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

• 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 Modernas values

Heres What Youll Bring to the Table:

• 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 experience in oncology required. Experience in immuno-oncology desirable. Experience in ultra rare disease desirable but not required. The ideal candidate has experience with high complexity clinical trials and late-stage clinical trials including inspection readiness activities.

• 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

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness mindfulness and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Our Working Model

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.