Full-Time

Associate Director

Clinical Biomarker

Posted on 10/2/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Cambridge, MA, USA

Expected to be in office 70% of the time with flexibility to work from home up to 30%.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
Google Cloud Platform
Requirements
  • MS (with at least 8 years pharmaceutical/biotechnology experience) or PhD (with at least 2-4 years 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.
  • Experience in Infectious disease programs (Ex: Human respiratory viruses / Human herpes viruses / HIV / Human Flaviviruses / Bacterial diseases) is highly desirable.
  • Diagnostic assay development and testing experience 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 skills.
Responsibilities
  • Evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of Moderna’s vaccines.
  • Develop biomarker plans with input from the research and clinical leads.
  • 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.
  • Ensure the timely and efficient delivery of all biomarker operational aspects across vaccine 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 Biosample Operations Manager.
  • 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 single point of contact for biomarker operations across vaccine teams, and with collaborators, assay labs and CROs.
  • Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leads.
  • Manage the development and oversight of the biomarker analysis timelines, budget, risk and quality plans.
  • Attend operations team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver trainings on biomarker activities.
  • Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treating diseases. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the speed and efficiency of drug discovery and manufacturing. The company's goal is to improve patient outcomes by harnessing the power of mRNA to create effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

3%

1 year growth

15%

2 year growth

53%
Simplify Jobs

Simplify's Take

What believers are saying

  • Expansion into mRNA vaccines for bird flu opens new market opportunities.
  • Collaboration with OpenAI enhances research and development capabilities through AI.
  • Strong financial performance with $1.9 billion in third-quarter revenues indicates growth potential.

What critics are saying

  • Legal challenges over intellectual property rights could impact financial stability.
  • Public hesitancy towards COVID-19 vaccinations may affect vaccine uptake and sales.
  • Expansion into China exposes Moderna to geopolitical risks and regulatory challenges.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for new therapeutic areas like autoimmune diseases.
  • The company has opened a world-leading vaccine facility in Victoria, enhancing production.
  • Moderna's strategic investment in China boosts its manufacturing capabilities and market presence.

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