Associate Director, Development Sciences Operations

Denali Therapeutics

South San Francisco (CA)

On-site

USD 171,000 - 223,000

Full time

2 days ago
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Job summary

Denali Therapeutics is seeking an Associate Director of Development Sciences Operations in South San Francisco to lead cross-functional program delivery. The role oversees staff, vendors, and study execution while ensuring GLP/GCP compliance and timely results.

The ideal candidate has 9+ years in biopharma development operations, with strong leadership and vendor management experience within a matrixed organization.

Qualifications

  • Experience leading Development Sciences Operations teams.
  • Knowledge of nonclinical and clinical development operations.
  • Experience with CROs, vendors, and outsourced studies.

Responsibilities

  • Lead Development Sciences Operations across programs, overseeing staff, vendors, and study execution.
  • Develop reports, set goals, coach direct reports.
  • Interface with CROs, establish workflows, expectations, and oversight.
  • Manage vendor selection, contracting with Legal and Finance.
  • Oversee nonclinical and clinical studies, ensuring timelines, quality.
  • Coordinate cross-functional activities to support program delivery.

Skills

People management
Vendor management
Cross-functional coordination
Program management
Communication

Education

Bachelor’s degree in Pharmacology/Toxicology/Pharmaceutical Sciences

Job description

Associate Director, Development Sciences OperationsWe use cookies on this site to enhance your user experience. By using Denali's career site, you are agreeing to our Privacy Notice, including our Cookie Statement.### Associate Director, Development Sciences OperationsApply: South San Francisco: Full time: Posted Yesterday: R-1706Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicleTM 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 environmentSalary 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/careersThis 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.
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