Senior Manager, Oncology Clinical Biomarkers

2 weeks ago


Cambridge, Massachusetts, United States Moderna Therapeutics Full time

Position Overview:
Moderna Therapeutics is on the lookout for a Senior Manager specializing in Clinical Biomarkers to spearhead and implement biomarker strategies across our clinical Oncology initiatives. This role will report directly to the Associate Director of Oncology, Clinical Biomarkers.

The Senior Manager will collaborate closely with both internal teams and external contract research organizations (CROs) to ensure the effective planning, execution, and timely delivery of biomarker laboratory data for clinical trials.


Key Responsibilities:

Utilize extensive knowledge and technical skills in various biomarker assays, particularly in the realm of immuno-oncology, including but not limited to immunogenicity, immunophenotyping, TCR sequencing, and immunohistochemistry.

Lead the development and implementation of assays within the clinical biomarker team by partnering with preclinical and clinical laboratory teams to assess current assay capabilities and identify any vendor or internal laboratory needs for oncology projects.

Oversee vendor relationships to ensure the timely and precise completion of tasks while addressing any issues that may arise.

Provide operational insights and recommendations for all study-related documentation, including protocols, lab manuals, informed consent forms, and amendments, ensuring the collection, delivery, and analysis of biological samples comply with these documents and adhere to GCP/ICH standards.

Contribute to the assessment of biomarker vendors by offering technical expertise in biomarker assays.


Qualifications:

A PhD with a minimum of 1 year of experience in the pharmaceutical or biotechnology sector, or an MS with at least 6 years of relevant experience in a related scientific discipline (e.g., immunology, oncology) is required.

Hands-on experience with biomarker assays such as cell-based immunogenicity assays, multiparametric flow cytometry, and multiplex cytokine assays is essential.

Experience managing clinical biomarker CROs is a must.

Familiarity with biomarker assay qualification and validation requirements, as well as experience in regulated environments (CLIA, GCP/GCLP, or equivalent), is preferred.

Demonstrated experience in applying biomarkers throughout clinical development, including clinical translational research, development, validation, and implementation of biomarkers in oncology, is required.

Strong communication, organizational, and documentation skills are essential.


Benefits:

Moderna offers a comprehensive and innovative benefits package, including:

  • Competitive medical, dental, and vision coverage options
  • Flexible Spending Accounts for medical and dependent care expenses
  • Lifestyle Spending Account for personal enrichment and self-care
  • Family care benefits, including subsidized back-up care and tutoring
  • Access to fitness, nutrition, and mindfulness classes
  • Exclusive discounts on fitness equipment
  • Adoption and family-planning benefits
  • Generous paid time off, including vacation, sick leave, and holidays
  • Paid sabbatical after 5 years of service
  • Comprehensive parental leave policies
  • 401k matching and financial planning resources
  • Life, LTD, and STD insurance options
  • Concierge services for various personal needs
  • Parking or commuter pass subsidies

At Moderna, we believe in fostering a culture of belonging and are committed to diversity and inclusion in our workforce. We strive to create an environment where every employee can thrive and contribute their best.

Join us in our mission to transform medicine and make a significant impact on the world.



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