Sr. Manager, Biomarker Program Specialist (Oncology), Clinical Biomarkers

The Role:

The Senior Manager of the Biomarker Program Specialist team will be responsible the management of vendors involved in clinical stage program biomarker analysis across Modernas oncology portfolio. The successful candidate will work closely with Program Specialists, Biomarker Leads, Finance, Contracting/Outsourcing, Alliance Management, Quality, Stats, Data Management, Biomarker Operations, and other stakeholders to ensure that critical timelines are met by our bioanalytical vendors and that those timelines accurately capture any program or study level changes. This position will communicate across multiple clinical teams, senior leadership and vendors. The primary focus of the position will be in the Oncology therapeutic area. 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.

Heres What Youll Do:

• Work with the Biomarker Program Specialist group, focused on the oversight of timelines and delivery of bioanalytical data from vendors

• Become a point of contact for vendor engagements and responsible for those engagements

• Manage multiple vendors for high priority programs across the entire Moderna pipeline

• Understand and participate in the strategic selection of key external partners for clinical biomarker and bioanalytical 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 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.

Heres What Youll Bring to the Table:

• Graduate degree with 3+ years of experience in a biotechnology or pharmaceutical setting or Bachelors degree with 5+ years of experience

• Project/program management training or certification preferred

• Bioanalytical or CRO experience

• 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.

• 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 organizationalaptitude

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

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