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Principal Research Associate, Study Manager Non-Clinical Operations

Company: Moderna Theraputics
Location: Cambridge
Posted on: July 30, 2022

Job Description:

The Role:

The Nonclinical Sciences Operations team at Moderna is looking for an agile, high-performing, and broadly skilled individual to contribute to the successful execution of GLP and nGLP in vivo studies in both 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 workload to meet project timelines.

Here's What You'll Do:

* As a key contributor to the success of Nonclinical 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' toxicology, pathology, DMPK and bioanalytical and internal cross functional partners (CMC, Analytical Development and Platform Research) to execute and manage outsourced studies


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


* Review and approve study designs/requirements and overall workflows to enable study conduct


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


* Keep internal systems updated with regards to study timeline and milestones and deliverables as they relate to regulatory filings or project individual needs


* 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:

* Life sciences BS degree with 5+ years of relevant pharmaceutical/biotech nonclinical 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 including knowledge of adjacent analytical chemistry, bioanalytical assay, DMPK or other CRO study monitoring experience a plus.


* Relevant knowledge/experience of CRO workflows in support of method development, qualification and validation of required assays to support in-life data deliverables. Bioanalytical and DMPK experience a plus


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


* Very 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



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.

#LI-NB1

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Keywords: Moderna Theraputics, Cambridge , Principal Research Associate, Study Manager Non-Clinical Operations, Healthcare , Cambridge, Massachusetts

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