Associate Director, Biomarker Operations

The Role:

The Associate Director of Global PBMC Operations will be responsible for the operation and management of Moderna’s PBMC clinical site network. The successful candidate will work closely with Clinical Operations, Clinical Biomarker teams, clinical sites, external partners, and other key stakeholders to ensure critical timelines and operational expectations are met by our PBMC site network and its partners. This position will communicate across multiple clinical teams, senior leadership, and external vendors/sites and report to the Director of Biomarker Operations. The focus of the position will be to operationalize and expand our current PBMC network globally, including study start up and site management. The ideal candidate will have project management, clinical operations, biomarker sample operations, PBMC processing, and vendor oversight experience, preferably including late-stage clinical programs.

Here’s What You’ll Do:

• Provide strategic input for the selection of new sites to be added to the PBMC network

• Support contracting and onboarding of clinical PBMC network sites

• Manage training of clinical site staff in PBMC processing and related procedures to establish and maintain quality PBMC processing

• Draft and review documentation needed for PBMC processing activities: SOPs, templates, eCRFs, etc.

• Engage with sites and vendors regarding PBMC processing and the network, including participation in Site Investigator Meetings, as well as site and vendor visits

• Aid clinical protocol teams with inclusion of PBMC processing into clinical trials

• Maintain awareness of ongoing or upcoming clinical trials that include PBMC processing

• Manage and track requests for new clinical sites to be integrated into the PBMC Clinical Site Network

• Maintain internal and external PBMC Resource Hubs for Moderna, In-Network and Out-of-Network sites

• Lead internal communication of performance test results for sites in the PBMC Clinical Site Network

• Implement project management processes for reporting, tracking, data collection, budgets, forecasting, as well as risk and stakeholder management

• Drive effective decision-making at the program and senior leadership level through:

  • Effective meeting management

  • Proactively identifying and escalating gaps and challenges along with potential solutions

  • Proactive communication that is outcome and solution-driven

• Work with the Finance group to forecast, implement and track program budgets

• Expand PBMC network to meet clinical development needs. This may include hiring and supervising support staff.

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

• Graduate degree with 5 years of experience in a biotechnology or pharmaceutical setting or Bachelor's degree with 10 years of experience

• Willing to travel up to 25%

• Experience with PBMC processing and Clinical Site Management/Operations

• General subject matter expertise in late-stage drug development across Phase 1-3, submission, post marketing (i.e., Phase 4) and lifecycle development (end to end R&D)

• Experience with clinical laboratory management, laboratory auditing and specimen processing

• Experience with GCP and GCLP compliance and applicable regulations and guidelines

• Strong personal skills to influence and motivate others Strong written and oral communication skills

• Strong organizational skills

• Preferred: Project management training or certification

• Preferred: CRO experience

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, 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.

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 leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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