Associate Director, NDDS Study Managemen
Moderna Therapeutics

Job Order #: 21082765

Cambridge, MA 02141

Full Time

40 hours per week

POSTED 7/8/2024

EXPIRES 10/1/2024

Job Description

The Role

At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individual's contribution is vital.

In this role, you will serve as the Associate Director, Nonclinical Drug Development Science (NDDS), Study Management & Outsourcing. You will apply your people management and subject matter expertise in the execution of nGLP and GLP in vivo studies in both discovery and development programs to drive platform and program initiatives. Excellent leadership and communication skills and comfort working in a dynamic, fast-paced, cross-functional team environment are required.

Here's What You'll Do

* Lead the NDDS, Study Management and Outsourcing (SMO) team in alignment with the corporate mindsets, to execute on Moderna's ambitious and dynamic agenda to deliver transformational medicines and vaccines to patients.

* Collaborate broadly with nonclinical functional area representatives and leaders in toxicology, pathology, DMPK and bioanalytical, as well as with cross functional partners (CMC, Analytical Development and Platform Research), to execute and manage the outsourcing of research and nonclinical activities to external vendors/CROs

* Provide outsourced study management oversight and training in protocol development, test article projections and shipments, and review of study deliverables (reports, CTD tables, SEND datasets) and ensuring NDDS alignment and standards are maintained.

* Participate in development and implementation of a strategy for outsourcing nonclinical activities. Support CRO quality oversight.

* Accountable for defining and managing the overall workflows to enable study conduct and execution of milestone deliverables in a timely manner.

* 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.

* Anticipate, troubleshoot and suggest solutions for study-related issues that arise and appropriately escalate as needed for resolution.

* Support business operations in the execution of SOW, invoices, budget monitoring and quarterly budget reviews

* Manage and prioritize multi-factorial and fluid timelines.

* In addition to people management and mentorship and serving as Head of the SMO function, the incumbent will also serve as an independent contributor for a select number of programs/studies as a Study Monitor/SMO Lead.

Here's What You'll Need (Minimum Qualifications)

* A BSc in life science or relevant scientific field (e.g., Biology, Biomedical Sciences, Chemistry, Pharmaceutical Sciences).

* A graduate degree and/or post-graduate qualification in a relevant discipline preferred.

* 7+ years of experience in the pharmaceutical/biotech industry, with substantial experience in nonclinical in vitro and in vivo (rodent and non-rodent) study execution and study management experience using small molecules and biologics and knowledge of Good Laboratory Practices

* 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
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How To Apply


320 Bent St.
Cambridge, MA 02141

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Moderna Therapeutics


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320 Bent St.
Cambridge, MA 02141