Associate Director, Development Sciences Operations

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Job summary

Denali Therapeutics Inc. seeks a senior leader to oversee Development Sciences Operations across nonclinical and clinical programs, ensuring quality, compliance, and timely study delivery.

You will manage staff and vendors and coordinate with Discovery, Development Sciences, and Clinical Operations to support program milestones. You will drive process improvements, maintain GLP, GCP, and GCLP standards, and partner with Legal and Finance on budgets and contracting to enable efficient study

Qualifications

• Bachelor’s degree in Pharmacology, Toxicology, Pharmaceutical Sciences, or related field.
• Typically requires 9+ years of biopharmaceutical experience with progressive responsibility in development sciences or operations.
• Experience managing CROs, vendors, and outsourced study execution.
• Strong communication, problem-solving, and organizational skills in a fast-paced environment.

Responsibilities

• Lead Development Sciences Operations activities across programs, including oversight of staff, vendors, and study execution.
• Manage staff development, 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 (IACUC), and internal SOPs.
• Drive operational improvements, standardization, and efficiency across Development Sciences activities.

Skills

Staff management

CRO management

Vendor management

Timeline management

Communication skills

Problem solving

Organizational skills

Education

Bachelor’s degree in Pharmacology, Toxicology, Pharmaceutical Sciences, or related field

Job description

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

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

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.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

“Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.