Associate Director, Clinical Biomarkers, Oncology

Location
Cambridge, MA
Posted
May 05, 2022
Ref
R7391
Required Education
Masters Degree/MBA
Position Type
Full time

The Role:

Moderna is seeking a Clinical Biomarker leader to drive biomarker assay plans across clinical stage Oncology programs. This position is located in Cambridge, MA and reports to Moderna’s Director of Clinical Biomarkers, Oncology. The Associate Director, Clinical Biomarkers, Oncology will work collaboratively across several clinical teams (internal, external CROs) to ensure biomarker assay development strategy, planning, execution and data delivery of biomarker lab data for clinical trials conducted by Moderna.

Here’s What You’ll Do:

  • Evaluate technologies to identify, define and implement fit for purpose biomarker assays to support the clinical development of Moderna’s Oncology pipeline.

  • Work in collaboration with clinical biomarker lab, translational and research teams to support overall biomarker assay development strategies for Oncology programs and bring a deep understanding of relevant biomarker technologies to teams

  • Bring deep technical knowledge and hands on experience of molecular biomarker technologies such as NGS, Immunoassays, Immunophenotyping, Image based assays and emerging technologies such as cell free DNA assessments.

  • Have a broad understanding of new technological advances in Oncology and potential utilization of these to address current and future needs within the Oncology portfolio

  • Lead assay development/implementation efforts in clinical biomarker team by partnering with preclinical and clinical biomarker lab teams to understand current assay status and potential vendor or internal laboratory requirements for Oncology programs.

  • Responsible to ensure assay labs complete appropriate development, qualification or validation studies in order to execute the clinical biomarker plan on time and with good quality for Oncology clinical biomarker assays

  • Manage biomarker assay labs to complete appropriate development, qualification or validation studies in order to execute the clinical biomarker plan on time and with good quality.

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

  • PhD (with at least 3 years pharmaceutical/biotechnology experience) or MS (with at least 8 years of pharmaceutical/biotechnology experience in an Oncology science, expertise in clinical biomarker assay development in highly desirable

  • Hands on experience in Immuno-Oncology assays, such as NGS, Flow based assays, multiplex immunofluoresceice, immunohistochemistry etc. are required  

  • Experience in 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.

  • Strong communication, organization and record keeping skills are required.  

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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