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Study Coordinator/Monitor Associate, Non-Clinical Sciences Operations at Moderna Therapeutics

Posted in Other 30+ days ago.

Location: Cambridge, Massachusetts





Job Description:

The Role:
The Non-Clinical Sciences team at Moderna is looking for an experienced, agile, high-performing, and broadly skilled individual to contribute to the successful execution of discovery and development programs. The majority of this work will be done in collaboration with internal partners and executed at external contract research organizations (CROs). The successful candidate will be able to manage and prioritize multiple concurrent work streams with a positive and collaborative mentality and with the ability to manage their workload to meet project timelines.

Here's What You'll Do:


  • As a key contributor to the success of Non-Clinical Sciences and a member of the operations team you will leverage operational and scientific knowledge and best practices to advance Moderna drug candidates at various stages of research and development


  • Collaborate broadly with NCS functional area scientists in Toxicology, Pathology, DMPK and Bioanalytical and with internal cross functional partners (CMC, Analytical Development and Platform Research) to execute and manage outsourced studies.


  • Support Senior Study Monitors/NCS Project Leads to ensure quality and on time deliverables for Moderna scientific and business needs


  • Engage key internal stakeholders to support all aspects of study enablement, execution and reporting.


  • Support management of protocol and report review, including coordination and execution of protocol and report review workflows and meetings.


  • Manage documentation related to outsourced studies (e.g. quotes, POs, protocols, critical reagents, shipping, data, and reports)


  • Maintain study tracking tools and study calendars


  • Review and QC of Non-Clinical toxicology, pathology, and DMPK data, data tables and reports.


  • Collaborate and provide input cross-functionally on best practices for laboratory techniques, study development, conduct, data deliverables and reporting processes with a keen eye on efficiency and creativity in approach.


  • Manage multi-factorial and fluid timelines


  • Travel up to 10% (domestic and/or international)


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


  • Bachelor's degree in Life Science with 2-4 years relevant pharmaceutical/biotech Non-Clinical study execution and study management experience, with knowledge of Good Laboratory Practices


  • Pharma/biotech experience with a broad understanding of Non-Clinical Sciences (Pre-Clinical) deliverables in both small molecule and biologics R&D space (Exploratory and Development)


  • Relevant knowledge/experience of CRO workflows including in life study conduct, in life procedures, protocol best practices and report coordination. CRO study monitoring experience a plus.


  • Proficient with Windows-based applications (e.g. Excel, Word, Outlook, Teams, SharePoint, PowerPoint, Smartsheet).


  • Strong written and oral communication skills


  • Successful candidate will be curious in exploring mRNA drug discovery and development, bold in proposing creative ideas and creative solutions to their work. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes


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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