Senior Manager, Research Operations
Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes preclinical programs in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com
Voyager is seeking a detail- and goal-oriented Senior Manager to join our team Research Operations team. The Senior Manager, Research Operations will be providing program management oversight for our Translational Research Group. In this exciting role, the individual will work closely with the Head of Translational Research, Business Operations, Program Leads, and other internal stakeholders to ensure critical timelines are met by both the internal Translational Research team and and/or external vendors.
The Senior Manager, Research Operations, in partnership with the Translational Research Head, will ensure that bioanalytical assays (including non-GLP and GLP) are successfully transferred, qualified, or validated at CROs and implemented for non-clinical study support. The incumbent will be responsible for the management of bioanalytical, histology, and NHP CROs involved in Voyager’s pre-clinical stage gene therapy programs. The ideal candidate will have hands on bioanalytical assay development or tracking in vivo studies at CROs, vendor oversight, and program management experience with pre-clinical programs.
Position Specific Responsibilities:
- Partner with the Head of Translational Research to shape program execution plan.
- Build, monitor, and maintain functional timelines/dashboards to ensure Translational Research activities are executed on time.
- Partner with R&D Business Operations to create a strategic outsourcing model for relevant Translational Research functions.
- Provide Program Management PM support to coordinate and execute studies at CROs and track in-house work.
- Partner with program and functional leads to draft study designs, SOWs, protocols and manage study documentation.
- In collaboration with Program and Functional Leads, ensure all data, parameters, and results are captured correctly.
- Work with VYGR Finance to implement and track the Translational Research budget and accrual of work at CROs.
Specialized Knowledge and Skills
- Bachelor’s degree with 8+ years of experience in an industry setting.
- 5+ years hands-on experience managing CRO activities.
- Experience with the development of bioanalytical assays preferred.
- Hands-on experience working in a regulated GLP environment is a plus.
- Excellent communication and presentation skills as well as organizational aptitude.
- Attention to detail and ability to work under tight timeline.
- Ability to work cross functionally efficiently, influence without authority, and manage conflict.
- Hands on experience with program / project creation and tracking applications (e.g., Microsoft Project, Smartsheet etc.)
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