Manager, Development Sciences Operations

Role Summary

The Development Sciences Operations Manager will oversee technical and operational aspects of Development Sciences workflows, including those conducted at external CRO laboratories in support of Toxicology, Pathology, Biomarker, Bioanalytical, and DMPK/Clinical Pharmacology functions. They will collaborate with Discovery Research and Development Sciences and work with cross-functional teams to liaise with Contract Research Organizations (CROs), monitor studies, manage vendor relationships and contracts, and contribute to the design, execution, and reporting of nonclinical studies for Denali Therapeutics products.

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.

Qualifications

• 3+ years of biopharmaceutical industry experience with a BS/MS in Toxicology, Pharmacology, Biological Sciences or related discipline.
• 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.

Education

• BS/MS in Toxicology, Pharmacology, Biological Sciences or related discipline.