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 Modernas 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.
Heres What Youll Do:
Develop Modernas platform approach and framework for site monitoring strategies and activities including but not limited to:
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.
Provide a framework for study teams to ensure adequate sponsor oversight of outsourced monitoring activities
Be a partner to Clinical Operations Therapeutic Area leaders in aligning these strategies
Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the subject matter experts (SMEs) for all risk-based monitoring approaches
Support the development of an innovative mindset and drive adoption of process that drives efficiency to support monitoring oversight and accountability
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 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
Responsible, in alignment with cross-functional stakeholders and leadership, in determining the appropriate outsourcing strategy for monitoring and monitoring oversight
May include review and approval of oversight assessment visit reports
Identify trends and escalate significant issues and findings in a timely manner
Accountable for oversight and management of the performance of external vendors in the site monitoring space
Accountable for envisioning and creating tools, templates, and procedural documents related to site monitoring activities
Evolve and maintain Modernas monitoring plan template including review and annotation of monitoring-related documentation
Establish and enhance analytic capabilities to enable a proactive approach to compliance and sponsor oversight
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
Lead, manage, and build out roles and responsibilities for a team of internal associates responsible for monitoring strategy, execution, and oversight
Includes line management responsibility for Monitoring Strategy and Execution associates
Coordinate training and onboarding of new employees
Ensure training compliance with internal procedures and processes
Set clear performance objectives and development plans
Ensure communication tools are in place and maintained to enable effective collaboration
Heres What Youll Bring to the Table:
Bachelors degree required; advanced degree preferred
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
Direct experience as a site monitor, Lead CRA, and/or CRA Manager
Knowledge and understanding of ICH GCP and other applicable guidelines
Extensive experience with cross functional operational management and collaboration
Extensive experience with managing CROs and other vendors performing monitoring or oversight activities
Track record of establishing effective business relationships with internal and external customers
Line management experience and demonstration of successful coaching, mentoring and development of team members
Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe
Ability to develop and evaluate business cases and effectively manage budgets
Excellent written and verbal communication skills
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
Flexibility to adapt to the dynamic needs of a growing company
Solid understanding of drug development across all phases and multiple therapeutic areas
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!
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at firstname.lastname@example.org. (EEO/AAP Employer)