Associate Director, Clinical Biomarker Program Specialist
ModernaTX, Inc.

The Role:

The Associate Director of the Biomarker Program Specialist (Oncology) team will be responsible the management of different internal teams and external vendors involved in clinical stage program bioanalytical analysis across Moderna's oncology franchise. The successful candidate will work closely with, Biomarker Leads, Biomarker Program Specialist, Finance, Contracting, and other stakeholders to ensure that critical timelines are met by our bioanalytical vendors and internal labs and that those timelines accurately capture any program or study level changes. This position will communicate across multiple development teams, senior leadership, and vendors. The ideal candidate will have area expertise within Oncology focused program management, bioanalytical assay development, and vendor oversight experience, preferably with late-stage clinical programs.

Here's What You'll Do:

• Form a Biomarker Program Specialist group, focused on the oversight of timelines and delivery of bioanalytical data from vendors and internal labs
  
• Become a point of contact for vendor engagements and responsible for those engagements
  
• Manage multiple vendors for high priority programs across the entire Moderna Oncology pipeline
  
• Understand and participate in the strategic selection of key external partners for Biomarker assessment
  
• Maintain and grow partnerships with key external oncology vendors across multiple biomarker areas, including immunoassays, multiplex immunofluorescence, immunohistochemistry, genetic, and flow cytometry assays.
  
• Implement and/or optimize core Program Management tools/processes for reporting, tracking, data collection, synthesis, budgets, integration, scenario-planning, risk and stakeholder management.
  
• Be a thought partner to the Biomarker leads to problem-solve, aid in implementing strategies that drive maximum potential realization, and shape the direction of the program.
  

• Drive effective decision-making at the Program and senior leadership level through:
  
  • Engagement with key stakeholders, including clinical development teams, data management, statistics and finance leads
    
  • Effective meeting management
    
  • Proactively identifying and escalating gaps and challenges along with potential solutions
    
  • Manage the biomarker program analyst team through challenging timelines and prioritizations
    
  • Proactive communication that is outcome and solution-driven
    
• Have visibility, bandwidth, and influence to drive completion of all deliverables and key responsibilities, building and leveraging relationships with key stakeholders (team members and leadership) and organizational dynamics to promote program goals.
  
• Work with the Finance group to implement and track program budget and find/suggest trade-offs as needed.
  

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

• Graduate degree with 5+ years of experience in a biotechnology or pharmaceutical setting or Bachelors degree with 10+ years of experience
  
• Project/program management training or certification preferred
  
• Experience with Immuno-Oncology assays, such as NGS, Flow based assays, multiplex immunofluorescence, immunohistochemistry etc. are required
  
• Experience in oncology CRO management, biomarker assay qualification/validation, familiarity with assay development under regulated environment (CLIA, GCP/GCLP or equivalent) is preferred.
  
• Solid experience in the application of biomarkers during clinical development including experience with clinical translational research, development, validation, and implementation of biomarkers in the oncology space.
  
• Generally 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).
  
• Core Program Management strengths with tools and best practices for reporting, tracking, data collection, synthesis, budgets, integration, scenario-planning, risk and stakeholder management.
  
• Demonstrated high-level cross-functional leadership and integration across large complex Programs and assuring alignment with Program leadership, stakeholders, and enterprise priorities.
  
• Strong track-record in implementing strategies that drive maximum potential realization
  
• Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally.
  
• Strong personal skills to influence without authority, motivate others and manage conflict.
  
• Strong written and oral communication skills as well as demonstrated organizational aptitude
  
• Preferred: Project/program management training or certification
  
• Preferred: Experience with oncology/immune-oncology focused studies
  

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 winter shut down
  • 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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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 committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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