Director, Monitoring Strategy And Execution

The Role:
Reporting to the Senior Director of Clinical Site Management and Monitoring (CSM&M), the Director of Monitoring Strategy and Execution plays an integral role in the strategic development, oversight, and execution of global monitoring conduct across Moderna’s entire clinical trial portfolio, including Therapeutics, Oncology and Infectious. This role will collaborate closely with key cross-functional internal stakeholders, including Clinical Risk Management Strategy, Clinical Operations, Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality of monitoring conduct and oversight from study start up through close out. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment. Applicants should be outstanding team members with the ability to effectively lead a team and to communicate with and influence both internal and external stakeholders.
Here’s What You’ll Do:

• Lead, manage, and build out roles and responsibilities for a team of internal associates responsible for monitoring strategy, execution, and oversight
• Understanding the differences in strategies, needs and approaches across multiple therapeutic areas and all phases of development and translate that into an appropriate risk-based approach to monitoring and oversight, accounting for the needs of on-site and remote monitoring, central monitoring, data collection, compliance, issue management, etc.
• Includes line management responsibility for Monitoring Strategy and Execution associates
• Ensure training compliance with internal procedures and processes
• Responsible, in alignment with cross-functional stakeholders and leadership, in determining the appropriate outsourcing strategy for monitoring and monitoring oversight
• Set clear performance objectives and development plans
• Develop and implement a monitoring oversight strategy, inclusive of management both internally and of an external vendor(s) to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans
• Accountable for oversight and management of the performance of external vendors in the site monitoring space
• Support the development of an innovative mindset and drive adoption of process that drives efficiency to support monitoring oversight and accountability
• Be a partner to Clinical Operations Therapeutic Area leaders in aligning these strategies
• Liaise with the Clinical Risk Management Strategy, Clinical Operations, and Central Monitoring teams to drive a risk-based approach to monitoring and ensure adequate and appropriate handoffs
• Develop key performance indicators (KPIs) and key quality indicators (KQIs) for implementation with monitoring plans and processes
• Lead where appropriate, and participate and support internal audit and regulatory inspection activities related to site monitoring and sponsor oversight
• Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the subject matter experts (SMEs) for all risk-based monitoring approaches
• Evolve and maintain Moderna’s monitoring plan template including review and annotation of monitoring-related documentation
• Coordinate training and onboarding of new employees
• Establish and enhance analytic capabilities to enable a proactive approach to compliance and sponsor oversight
• Identify trends and escalate significant issues and findings in a timely manner
• Develop Moderna’s platform approach and framework for site monitoring strategies and activities including but not limited to:
• May include review and approval of oversight assessment visit reports
• Provide a framework for study teams to ensure adequate sponsor oversight of outsourced monitoring activities
• Ensure communication tools are in place and maintained to enable effective collaboration
• Accountable for envisioning and creating tools, templates, and procedural documents related to site monitoring activities

Here’s What You’ll Bring to the Table:

• Excellent project management, leadership, communication, management, and organizational skills, as well as a high level of proficiency with problem solving, conflict resolution, negotiation and team building skills
• Extensive experience with managing CROs and other vendors performing monitoring or oversight activities
• Line management experience and demonstration of successful coaching, mentoring and development of team members
• Knowledge and understanding of ICH GCP and other applicable guidelines
• Excellent written and verbal communication skills
• Solid understanding of drug development across all phases and multiple therapeutic areas
• Flexibility to adapt to the dynamic needs of a growing company
• Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe
• Direct experience as a site monitor, Lead CRA, and/or CRA Manager
• Extensive experience with cross functional operational management and collaboration
• Ability to develop and evaluate business cases and effectively manage budgets
• Minimum of 10+ years of experience in clinical research and development, and at least 5+ years in roles focused on site monitoring, including direct experience in RBQM/RBM principles
• Bachelor’s degree required; advanced degree preferred
• Track record of establishing effective business relationships with internal and external customers

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

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

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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. We’re 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)
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