Associate Director, Development Sciences Operations
Denali Therapeutics
Summary
Leads Development Sciences Operations to support nonclinical and clinical development programs across Toxicology, Pathology, DMPK, Clinical, Pharmacology, Biomarkers, and Bioanalytical functions. Oversees operational execution, external partnerships, and study delivery to ensure quality, compliance, and timelines. Manages team members and vendors while driving cross-functional coordination and operational consistency across programs.
Job description
Key Accountabilities/Core Job Responsibilities:
- Lead Development Sciences Operations activities across programs, including oversight of staff, vendors, and study execution
- Manage and develop direct reports, including goal setting, performance management, and coaching
- Serve as primary operational interface with CROs, establishing workflows, expectations, and oversight
- Manage vendor selection and contracting (RFIs, SOWs, budgets, change orders) in partnership with Legal and Finance
- Oversee execution of nonclinical and clinical studies, ensuring timelines, quality, and compliance (GLP, GCP, GCLP)
- Coordinate cross-functional activities with Discovery, Development Sciences, and Clinical Operations to support program delivery
- Establish and track study timelines, risks, and deliverables to meet program objectives
- Ensure data quality, reporting, and integration into internal systems to support decision-making
- Ensure compliance with study protocols, regulatory requirements (e.g., IACUC), and internal SOPs
- Drive operational improvements, standardization, and efficiency across Development Sciences activities
Qualifications/Skills:
- Typically requires a Bachelor's degree in Pharmacology, Toxicology, Pharmaceutical Sciences, or related field (advanced degree preferred)
- Typically requires 9+ years of biopharmaceutical experience with progressive responsibility in development sciences or operations and management experience
- Demonstrates experience managing direct reports and leading work through others in a matrixed environment
- Demonstrates working knowledge of nonclinical and clinical development operations, including Toxicology, DMPK, and Bioanalytical workflows
- Demonstrates experience managing CROs, vendors, and outsourced study execution
- Demonstrates ability to manage programs, including timelines, risks, budgets, and cross-functional coordination
- Demonstrates strong communication, problem-solving, and organizational skills in a fast-paced environment
Requirements
- Bachelor's degree in Pharmacology, Toxicology, Pharmaceutical Sciences, or related field
- Advanced degree preferred
- 9+ years of biopharmaceutical experience with progressive responsibility in development sciences or operations
- Management experience
- Experience managing direct reports and leading work through others in a matrixed environment
- Working knowledge of nonclinical and clinical development operations, including Toxicology, DMPK, and Bioanalytical workflows
- Experience managing CROs, vendors, and outsourced study execution
- Ability to manage programs, including timelines, risks, budgets, and cross-functional coordination
- Strong communication, problem-solving, and organizational skills
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.