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.
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
Salary Range: $171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
