Moderna

Role Description Moderna Services, Inc. seeks a Sr. Manager, Clinical Data Management for its Cambridge, Massachusetts location. Here’s What You’ll Do: - Lead data management activities for in-house and outsourced studies. - Responsible for vendor oversight activities across global development programs. - Represent data management function in clinical cross-functional meetings, ensuring aligned expectations between the Contract Research Organization (CRO) and Moderna for all data related deliverables, especially in support of key decision points and regulatory submissions. - Ensure established milestones and deliverables are met with the highest degree of quality. - Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks. - Provide input to functional governance with Moderna strategic suppliers. - Partner with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams. - Lead and manage clinical trial data collection set-up, data review, and database lock for studies where data management activities are conducted within Moderna. - Work with other functions to complete set up of Electronic Data Capture (EDC) and study data collection tools such as Inter-response time (IRT), ePRO and eCOA. - Lead the creation and maintenance of study cross functional data review plan components, including: - Edit checks (data validation plan) - Listing review checks - Data integration specifications - Data transfer specifications - External data reconciliation plans - Coding guidelines - Serious Adverse Events (SAE) reconciliation guidelines - Database lock plans - Lead data review, including query management, and activities required for interim and final database locks. - Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. - Ensure achievement of major data management deliverables and milestones in coordination with the Clinical Operations Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance. - Plan and manage external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. - Act as a process expert for operational and oversight models. - Maintain Standard Operating Procedures (SOPs), process maps and templates and timelines to support functions operational and oversight models. - May prepare metrics to support the function Key Performance Indicators (KPIs). - Represent function in external professional initiatives and organizations such as SCDM, CDISC, and DIA to identify industry best practice and increase the visibility of Moderna. - Lead functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with requirements. - Work cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables. - Champion and adopt technology improvements and tools for use in clinical data management processes. - Ensure compliance with own Learning Curricula, corporate and GXP requirements. Qualifications - Requires a Bachelor’s degree, or foreign equivalent, in Biotechnology, Biology, Biological Sciences, or related field. - 8 years of progressive, post-baccalaureate experience as a Sr. Manager, Assistant Clinical Data Manager, Clinical Data Associate or related position supporting clinical data management for the pharmaceutical industry. - 7 years of experience must include: - Vendor Management - Medidata RAVE, InForm, and Oracle Clinical EDC tools - Clinical Data Management using Biomarker and External data - Utilizing eTMF tools - Study Database Lock processes including Final, Interim, Snapshots, DSUR submission, and Staggered Lock - Study Initiation, CSR Review, and SAE Reporting - J-Review, I-Review, and Clinbrowser - SDTM and CDISC datasets, Clinical Data Studio, SQL & SAS Requirements - 100% telecommuting permitted from anywhere within the US. 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. - The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

• Serve as the engineering subject matter expert for Moderna’s Privileged Access Management program, owning the CyberArk platform and its associated components. • Manage the configuration, administration, maintenance, and ongoing optimization of the CyberArk environment. • Collaborate with business units, application owners, and engineering teams to understand requirements and translate business needs into secure and scalable PAM solutions and technical designs. • Conduct stakeholder interviews and gather application, service, and infrastructure information to support CyberArk onboarding activities. • Define and articulate business and functional requirements based on evolving industry best practices, emerging technologies, and organizational needs. • Partner with DevOps, systems, network, cybersecurity, and infrastructure teams to ensure privileged access management standards are consistently implemented and maintained. • Perform application integration assessments and provide technical guidance on CyberArk integration approaches and options. • Lead and manage the onboarding of privileged accounts into CyberArk, ensuring adherence to established design frameworks and operational standards. • Develop and maintain end-user documentation, knowledge articles, standards, and training materials to support adoption and operational excellence. • Create detailed architecture documentation, implementation plans, technical standards, and solution designs. • Evaluate the existing PAM environment to identify technical, operational, and security enhancement opportunities, driving continuous improvement initiatives. • Participate in disaster recovery planning, capacity management, performance monitoring, maintenance activities, and platform resilience efforts to ensure high availability. • Work closely with Cybersecurity and Governance teams to ensure PAM solutions align with corporate security policies, regulatory requirements, and established standards. • Regularly review, evaluate, and enhance PAM policies, procedures, and controls to maintain strong security compliance and operational effectiveness. • Develop, support, and maintain security policies, standards, and operational processes related to privileged access management. • Stay current on industry trends, threat landscapes, emerging technologies, and evolving identity security practices to help ensure Moderna’s IAM and PAM strategies remain effective and future ready. • Contribute to the overall cybersecurity posture of the organization through adherence to security policies, procedures, and best practices. • Support emergency incidents and planned maintenance activities, including participation in 24x7 support requirements when necessary.

Lead clinical data management initiatives, ensuring compliance and quality across trials, while overseeing vendor relationships and data handling. Collaborate with cross-functional teams to achieve timely data deliverables and maintain inspection...

• Develop strategic account plans that will enhance customer relationships, achieve sales targets, facilitate retention and growth within targeted Wholesaler and Distributor customer accounts to support and oversee successful communication and negotiation • Act as the primary point of contact for Moderna for a defined set of accounts, analyzing and understanding trends for product sales to each account, achieving defined goals and objectives, developing expert knowledge of the products offered by the company to ensure an excellent understanding of the customer requirements and promoting a mutually beneficial business relationship while adhering to Moderna Core Values and Mindsets • Work with the US Commercial leadership team, within channels to establish & execute tactical initiatives reflected in dedicated business plans, which align with the business unit objectives. • Analyze account objectives for each product and develop strategic/tactical plans to accomplish brand business objectives. • Develop and maintain contacts within the industry to obtain environmental, competitive, and product-specific information • Build and maintain long-term relationships within defined customer bases to ensure customer alignment and create a foundation for new business • Collaborate and partner with internal and external stakeholders to enhance Moderna’s position in the market • Responsible for cultivating a close relationship with cross functional team colleagues in Medical Affairs, Marketing, Market Access, Distribution / Logistics, Customer Service, and Public Affairs departments to implement corporate, operational (shipping/inventory), market access and brand specific strategies and tactics. • Represent Moderna at key trade and customer meetings / conferences. • Promote Moderna portfolio of products to key customers that drives differentiation for Moderna and successful long-term business relationships • Collaborate with appropriate Moderna business teams, marketing, and medical affairs to ensure alignment and full utilization of resources at account level. This includes utilization of marketing materials, execution of in-services, development, and execution of marketing or other service agreements. • Liaise with Contracts, Commercial Operations, Legal, HR, and Finance to ensure successful outcomes for the responsible channels

• Full accountability for regional sales, revenue, and market share targets for Moderna’s vaccine portfolio • End-to-end ownership of regional business planning and execution, aligned with national strategy and adapted to local market dynamics (e.g. seasonality, vaccination programs, urban vs. rural coverage) • Leadership, steering, and performance management of the regional field force, including prioritization, target setting, coaching, and continuous development • Driving effective deployment of resources across territories to maximize impact and coverage • Establishing and expanding strategic partnerships with key physicians, vaccination centers, and pharmacies, beyond traditional engagement models • Designing and implementing innovative engagement formats, including digital HCP interactions, hybrid events, pharmacy-led initiatives, and scalable online/offline approaches • Acting as a regional role model and internal advocate for digital and data-driven commercial execution • Continuous analysis of regional market trends, competitive intelligence, and customer needs, translating insights into clear action plans and execution priorities • Close cross-functional collaboration with Marketing, Medical, Access, and Commercial Excellence teams

The Role Moderna is seeking a team of experienced candidate to support the commercialization of Moderna’s groundbreaking vaccine portfolio. In this role, you will be joining Moderna at both an exciting, as well as critical time as we commercialize our respiratory vaccine pipeline. Reporting to the Senior Director, you will be responsible for developing and enhancing customer relationships with largest vaccinators throughout your region. This includes Regional Health Systems, State Awardees/VFC, Federally Qualified Health Centers, Contracting Entities, Physician Groups and Specialty Providers. You will develop expert knowledge of Moderna’s respiratory vaccine portfolio/mRNA platform and use this along with your knowledge of strategic customer requirements to expand vaccination rates and achieve account sales targets. To be successful, you must thrive in a fast-paced, team environment and excel at developing high-level customer relationships with the procurement, business development, clinical, operational, trade management, and marketing teams within your region’s largest providers of health care services. This role is based remotely. Here’s What You’ll Do - Develop strategic account plans that will enhance customer relationships, achieve sales targets, facilitate retention and growth within key customers (IDNs, Health Systems, FQHCs, Awardees, Physician Groups, Contracting Entities, etc) to support and oversee successful communication and negotiation - Act as the primary point of contact for Moderna for a defined set of accounts, analyzing and understanding sales trends for product sales to each account, achieving defined goals and objectives, developing expert knowledge of the products offered by the company to ensure an excellent understanding of the customer requirements and promoting a mutually beneficial business relationship while adhering to Moderna Core Values and Mindsets - Work with your Sr. Director, within channels to establish & execute tactical initiatives reflected in dedicated business plans, which align with the business unit objectives. - Analyze account objectives for each product and develop strategic/tactical plans to accomplish brand business objectives - Develop and maintain contacts within the industry to obtain environmental, competitive, and product-specific information - Build and maintain long-term relationships within defined customer bases to ensure customer alignment and create a foundation for new business - Collaborate and partner with internal and external stakeholders to enhance Moderna’s position in the market - Responsible for cultivating a close relationship with cross functional team colleagues in Medical Affairs, Marketing, Distribution / Logistics, Strategic Partnerships, Customer Service, and Public Affairs departments to implement corporate, operational (shipping/inventory), market access and brand specific strategies and tactics - Represent Moderna at key trade and customer meetings / conferences. - Promote Moderna portfolio of products to key customers that drives differentiation for Moderna and successful long-term business relationships - Collaborate with appropriate Moderna business teams, marketing, and medical affairs to ensure alignment and full utilization of resources at account level. This includes utilization of marketing materials, execution of in-services, development, and execution of marketing or other service agreements - Liaise with Contracts, Customer Operations, Legal, HR, and Finance to ensure successful outcomes for the channels responsible. Here’s What You’ll Need (Basic Qualifications) - Bachelor’s Degree required - Minimum 10 years of experience in pharmaceutical/biotech account strategy and account management Here’s What You’ll Bring to the Table (Preferred Qualifications) - Prior experience in vaccines is highly preferred - Knowledge and understanding of product reimbursement - Demonstrated prior experience with establishing and consistently meeting or exceeding business development targets - Experience in a startup environment, preferably launching new vaccines or medicines - Experience working with complex Academic Medical Centers & teaching hospitals - Working Knowledge of capitated and risk-based providers and fundamentals of value-based care - Demonstrated track record of building and driving volume and profitable revenue growth with key corporate or private sector accounts - Ability to collaborate among a range of key areas (marketing, field team, communications, promotion, physician, trade and consumer channels, pricing and contracting, and/or buyers). - Strong portfolio of commercial skills obtained through experience and application with track record of delivery including negotiation, building a financial business case & working within commercial teams. - Must be comfortable with ambiguity and a fast-paced, highly dynamic environment that is being defined in real-time. You should be driven and willing to think creatively and pursue new or novel approaches to business and market development. The fast-moving market for vaccines will require a high degree of adaptability and trust building with key accounts - Experience leveraging data and digital enablement tools to prioritize opportunities across a dynamic landscape of potential and targeted regional accounts - Excellent communication, presentation, collaboration and influencing skills across internal and external stakeholders - A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. - 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 The salary range for this role is $142,500.00 - $256,500.00(for positions that may be performed in California, the expected salary range is $195,300.00 - $224,700.00, which reflects the range permitted under California Labor Code requirements) . This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. 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 modernatx.com/careers 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 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 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 We’re 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 leavesandaccommodations@modernatx.com.  - #LI-Remote

• Full accountability for regional sales, revenue, and market share targets for Moderna’s vaccine portfolio • End-to-end ownership of regional business planning and execution, aligned with national strategy and adapted to local market dynamics (e.g. seasonality, vaccination programs, urban vs. rural coverage) • Leadership, steering, and performance management of the regional field force, including prioritization, target setting, coaching, and continuous development • Driving effective deployment of resources across territories to maximize impact and coverage • Establishing and expanding strategic partnerships with key physicians, vaccination centers, and pharmacies, beyond traditional engagement models • Designing and implementing innovative engagement formats, including digital HCP interactions, hybrid events, pharmacy-led initiatives, and scalable online/offline approaches • Acting as a regional role model and internal advocate for digital and data-driven commercial execution • Continuous analysis of regional market trends, competitive intelligence, and customer needs, translating insights into clear action plans and execution priorities • Close cross-functional collaboration with Marketing, Medical, Access, and Commercial Excellence teams

The Role: Moderna is seeking a Senior Director, Litigation to lead and manage complex global litigation matters, including product liability defense, government investigations, regulatory enforcement actions, and commercial disputes. This role requires a seasoned litigator with a proven ability to assess, prioritize, and respond to legal risk in a strategic and scalable manner in the biotechnology, pharmaceutical, or life sciences industries. You will be a key legal strategist, advising leadership on high-exposure litigation risks and regulatory challenges while ensuring resources are deployed effectively based on the level of risk. Hands-on in-house experience managing high-stakes government investigations, regulatory enforcement actions, and external counsel in complex litigation is critical. You’ll also provide strategic foresight—not just responding to today’s risks, but helping the business anticipate and prepare for tomorrow’s legal challenges in an increasingly complex global environment. This high-impact role offers meaningful visibility to executive leadership and significant opportunity to shape Moderna’s long-term litigation strategy. Here’s What You’ll Do: Lead and execute Moderna’s global litigation strategy, overseeing a diverse portfolio of cases, including product liability, commercial disputes, and government investigations. Assess and prioritize litigation risk, ensuring that responses are proportionate to the level of risk and impact on the business, and advising leadership on when immediate, high-level engagement is required versus when a measured response is appropriate. Act as a lead strategist and decision-maker in high-exposure government investigations, subpoenas, and regulatory enforcement actions, ensuring Moderna’s responses are comprehensive, strategic, and aligned with business priorities. Demonstrate extensive hands-on litigation experience, including working directly with outside counsel, overseeing discovery, managing case strategy, and guiding settlement negotiations. Prepare and support Moderna employees for depositions, government interviews, and investigations, ensuring they are well-informed, protected, and aligned with legal strategy. Develop and implement internal protocols for handling subpoenas, regulatory inquiries, and litigation responses to ensure swift, effective decision-making. Proactively assess, prioritize, and mitigate legal risks, collaborating with internal stakeholders in Compliance, Regulatory Affairs, R&D, and Commercial to ensure legal strategies support Moderna’s business objectives. Advise senior leadership on high-profile legal matters, litigation trends, and evolving impacting the company’s global operations. Become a leader in leveraging generative AI and other advanced technologies in litigation strategy, discovery, and cost management—partnering with external counsel to implement forward-thinking, tech-enabled approaches that drive efficiency, enable favorable outcomes and surface actionable insights. Manage external counsel relationships strategically, ensuring alignment with business goals and optimizing litigation outcomes while maintaining cost-effectiveness. Here’s What You’ll Bring to the Table: Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. 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 The salary range for this role is $209,000.00 - $376,000.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. 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 modernatx.com/careers 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 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 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 We’re 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 leavesandaccommodations@modernatx.com. 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 applicant’s ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company’s ability to obtain any required export control license. #LI-AG2 -