Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology

The Role:

The Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology is a pivotal role within the Clinical OperationsTherapeutics and Oncology organization. tasked with the oversight of external resources dedicated to co-monitoring activities and site visitations globally, aligned to the larger overarching RBQM/Monitoring Oversight model and framework. This individual will also provide strategic input and oversee the implementation of cross-functional initiatives and solutions within Clinical Operations.

Heres What Youll Do:

Strategic Leadership Collaboration:

• Work closely with the Clinical Operations leadership team to align on priorities and desired outcomes related to Monitoring Oversight strategy in collaboration with centralized functions and Monitoring Oversight visits.

• Collaborate with Clinical Trials Execution & Support (CTE&S), R&D Quality, Patient Advocacy, Safety & Engagement, and Data & Digital teams to ensure integrated strategies and successful delivery of initiatives.

• Drive strategic planning and the integration of cross-functional initiatives that impact Clinical Operations globally.

Global Alignment and Communication:

• Ensure global consistency in monitoring strategies by coordinating global and regional resources in Clinical Operations and CTE&S) and Clinical Operations.

• Promote knowledge sharing and the dissemination of best practices across all regions and across Clinical Operations teams.

• Regularly update senior leadership on the progress of external co-monitoring activities and strategic initiatives.

Solution Implementation and Innovation:

• Lead the assessment and implementation of new technologies and process improvements, including developing business processes and oversight frameworks (e.g., SOPs, guidelines and other operational frameworks for utilization and oversight of capability).

• Provide expertise in Clinical Operations systems, supporting the adoption and training of new solutions.

• Oversee and manage the execution of Clinical Operations efforts.

• Represent Clinical operations in cross-functional efforts, ensuring Clinical Operations requirements are well-defined.

• Serve as a liaison between Clinical Operations and other departments to facilitate effective communication and project success.

Resource Oversight:

• Manage and oversee external vendors and partners for global co-monitoring activities and site visitations.

• Manage internal resources and team supporting Monitoring Oversight as applicable based on operating model.

• Ensure the quality and compliance of monitoring activities conducted by external resources align with regulatory standards.

• Develop and enforce SOPs and best practices for co-monitoring to ensure consistency and quality.

Heres What Youll Bring to the Table:

• Bachelor's degree in life sciences, healthcare, or a related field. Advanced degree preferred.

• Minimum of 8 years of experience in clinical research, with a strong focus on Clinical Operations and monitoring.

• Proven experience in managing external resources and vendors at a global level.

• Comprehensive understanding of global regulatory requirements and Good Clinical Practice (GCP).

• Demonstrated success in strategic planning and implementation within Clinical Operations, with a track record of driving organizational goals and initiatives.

• Exceptional leadership and team management capabilities, with the ability to inspire and motivate teams to achieve high-performance results.

• Strong analytical and strategic thinking skills, with the ability to identify opportunities, solve complex problems, and make data-driven decisions.

• Excellent communication and interpersonal skills, capable of effectively collaborating across various functions and cultures, and influencing stakeholders at all levels of the organization.

• Proficient in project management, with a proven ability to successfully lead and execute multiple projects in a fast-paced environment.

• Experience with people management of both internal and external resources.

• Experience in oncology required with additional experience in other complex diseases desirable.

• Expertise in clinical trial management systems (CTMS) and electronic data capture (EDC) systems, with a strong proficiency in leveraging technology for process optimization and efficiency gains.

Travel Requirements:

Ability to travel including internationally as necessary for the role (approximately 20%).

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.

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

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

Moderna 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 proud to be an equal opportunity workplace and is an affirmative action employer.

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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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