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Manager, Development Sciences Operations jobs in United States
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Denali Therapeutics · 15 hours ago

Manager, Development Sciences Operations

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. The Development Sciences Operations Manager will oversee technical and operational aspects of Development Sciences workflows and collaborate with cross-functional teams to manage vendor relationships and contribute to nonclinical study execution.
BiotechnologyGeneticsHealth DiagnosticsTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Serve as Safety Assessment (Toxicology/Pathology), DMPK, Clinical Pharmacology, Biomarker, and Bioanalytical function interface between Denali and external CRO collaborators, developing productive relationships to achieve optimal efficiency in external workflows in GLP, GCP and GCLP areas
Manage identification (RFI), partnering with Legal and Contracts group in managing the operational aspects of pre-clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets
Manage study operational logistics, including establishing timelines for deliverables, facilitate test material logistics, and support the trafficking of samples, data, and documents
Provide support in implementing, managing, and monitoring outsourced nonclinical Toxicology studies (non-GLP and GLP) to support all phases of drug development
Remote and onsite oversight of nonclinical studies to ensure studies are conducted to the highest standards
Responsible for working with DMPK scientists to identify CRO laboratories capable of conduct of in vitro and in vivo experiments supporting candidate identification and IND-enabling efforts
Engage CROs and internal scientists to outline protocols/SOWs
Receive and review study results and summary reports, ensuring data and reports are integrated into internal databases; help design tools to aid in data upload, migration, and visualization
Ensure compliance with study protocols, IACUC regulations, and SOPs

Qualification

ToxicologyPharmacologyBiopharmaceutical experienceData visualization softwareCRO managementAnalytical skillsOrganization skillsCommunication skillsTeam collaboration

Required

BS/MS in Toxicology, Pharmacology, Biological Sciences or related discipline with 3+ years of biopharmaceutical industry experience
Experience working with nonclinical CROs, developing protocols, and an understanding of technical and organizational aspects of study conduct, including knowledge of current animal welfare philosophies and 3Rs
Ability to perform data entry into data warehouses (e.g., Dotmatics/Benchling) and manage data visualization software (Tableau, SEND explorer)
Outstanding organization and planning skills, and the ability to assess risks and manage external workflows to meet project team deliverables
Excellent analytical, critical thinking, and soft skills to build collaborative relationships enabling effective professional interactions with vendors and stakeholders
Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit

Benefits

401k
Healthcare coverage
ESPP
A broad range of other benefits

Company

Denali Therapeutics

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Denali Therapeutics is dedicated to defeating neurodegenerative diseases to deliver safe and effective medicines to patients and families.

H1B Sponsorship

Denali Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (6)
2021 (5)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$1.32B
Key Investors
Royalty PharmaBaillie Gifford
2025-12-04Post Ipo Debt· $200M
2024-02-27Post Ipo Equity· $500M
2022-10-19Post Ipo Equity· $275M

Leadership Team

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Ryan Watts
CEO
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Peter Chin
Sr. Vice President & Head of Late-Stage Clinical Development and Medical Affairs
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Company data provided by crunchbase