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Sr. Director, Clinical Biomarkers - Infectious Disease

Company: Moderna Theraputics
Location: Cambridge
Posted on: June 6, 2021

Job Description:

The Role:

Moderna is seeking a Senior Director of Clinical Biomarkers to lead a clinical biomarkers group in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Moderna's VP of Clinical Biomarkers. The Senior Director will work collaboratively across multiple clinical teams as well as overseeing a team responsible for the entire ID portfolio within Moderna (internal, external CROs) to ensure strategy, planning, execution and data delivery of biomarker lab data for clinical trials conducted by Moderna.

Here's What You'll Do:

  • Lead a team of dedicated and senior Clinical Biomarker leaders with responsibility for all clinical biomarkers within Moderna's Infectious Disease pipeline

  • Collaborate with clinical and research teams to define overall biomarker strategies for programs

  • Oversee biomarker plans and strategy with input from research and clinical leads for ID studies

  • 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 ID clinical biomarker assays

  • Ensure timely and efficient delivery of all biomarker operational aspects across ID clinical trials: accountable for planning, coordinating, and overseeing all operational activities by the ID clinical biomarker team as 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 ID teams, and with collaborators, assay labs and CROs.

  • Contribute to the identification and selection of biomarker vendors and aid in building the strategy for the selection of those vendors

  • Represent ID teams on governance bodies, contribute to protocol writing, INDs and BLAs as well as attend CRO kick-off meetings to lead biomarker activities across the ID space

  • Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection

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

  • PhD (with at least 6 years pharmaceutical/biotechnology experience) in a related science focus on infectious disease.

  • Experience leading a team of clinical translational or biomarker leaders and deep understanding of the role of clinical biomarkers across drug development from early phase through licensure

  • Deep understanding of the regulatory expectations for pivotal biomarkers in clinical trials

  • Solid experience in the application of biomarkers during development of assets required including experience with clinical translational research, development, validation and implementation of biomarkers in the ID space.

  • Experience in managing third party assay laboratories, collaborations and budget management.

  • Strong communication and project management skills

Here'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.

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Keywords: Moderna Theraputics, Cambridge , Sr. Director, Clinical Biomarkers - Infectious Disease, Other , Cambridge, Massachusetts

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