Manager, Development Sciences Operations

Denali Therapeutics•South San Francisco, CA

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The company is seeking an experienced and highly motivated Development Sciences Operations Manager responsible for oversight of 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. This individual will work in close collaboration with colleagues in Discovery Research and Development Sciences and will be responsible for working with members of cross-functional teams to liaise with Contract Research Organizations (CROs), monitor studies, manage vendor relationships and contracts, and potentially contribute to the design, execution, and reporting of nonclinical studies for Denali Therapeutics products.

Requirements

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.

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.