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Sr. Manager/Manager, Clinical Biomarkers - Rare Disease

Company: Moderna Therapeutics
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Sr. Manager/Manager, Clinical Biomarkers - Rare Disease Cambridge, Massachusetts Clinical Development The Role:Moderna is seeking a Clinical Biomarker scientist to develop and drive biomarker plans across clinical stage Rare Diseases programs. This position reports to Moderna's Associate Director of Clinical Biomarkers. The Sr. Manager / Manager will work collaboratively across several clinical teams (internal, external CROs) to ensure 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 the biomarker plan to support the clinical development of Moderna's Rare Disease programs
  • Develop biomarker plans with input from research and clinical leads for Rare Disease studies
  • Manage biomarker assays 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
  • Ensure timely and efficient delivery of all biomarker operational aspects across Rare Disease clinical trials: accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery and final sample disposition with support from the Biomarker Operations
  • Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery and analysis of biosamples in compliance with these documents as well as GCP/ICH
  • Serve as a primary point of contact for biomarker operations across Rare Disease teams, and with collaborators, assay labs and CROs.
  • Contribute to the identification and selection of biomarker vendors
  • Manage development and oversight of the biomarker analysis timelines, budget, risk and quality plans
  • Attend operational team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver insight and trainings on biomarker activities
  • Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collectionHere's What You'll Bring to the Table:
    • MS (with at least 6 years pharmaceutical/biotechnology experience) or PhD (with at least 1-2 year of pharmaceutical or biotechnology experience) in a related science focus (i.e. immunology, molecular biology, biotechnology).
    • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
    • LCMS and Flow Cytometry knowledge is desirable
    • Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research, validation and implementation.
    • Experience in managing third party assay laboratories, collaborations and budget management.
    • Strong communication and project management skillsHere's What We'll Bring to the Table:
      • On-site subsidized cafeteria or catered lunches
      • Company-provided iPhone
      • Free parking, monthly subway pass or a subsidized commuter rail pass
      • Free annual corporate membership to Bluebikes
      • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
      • Flexible Spending Accounts for medical expenses and dependent care expenses
      • 16 weeks of 100% paid parental leave for all new parents
      • 16 weeks 100% paid family caregiver leave
      • 20 weeks 100% paid medical leave
      • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
      • Adoption assistance and discounts to local childcare centers, as well as access to care.com
      • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
      • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
      • Voluntary legal assistance plan
      • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays) About Moderna: In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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. #LI-AK1- Posted 30+ Days Ago Full time R3580 About Us Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Keywords: Moderna Therapeutics, Cambridge , Sr. Manager/Manager, Clinical Biomarkers - Rare Disease, Executive , Cambridge, Massachusetts

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