Associate Director, Development Sciences Operations

Denali•South San Francisco, CA

1d•$171,000 - $223,000

About The Position

The Associate Director, Development Sciences Operations leads operational support for nonclinical and clinical development programs across Toxicology, Pathology, DMPK, Clinical, Pharmacology, Biomarkers, and Bioanalytical functions. The role oversees operational execution, external partnerships, and study delivery to ensure quality, compliance, and timelines. It manages team members and vendors and drives cross-functional coordination and operational consistency across programs.

Requirements

Bachelor’s degree in Pharmacology, Toxicology, Pharmaceutical Sciences, or a related field.
Typically 9 or more years of biopharmaceutical experience with progressive responsibility in development sciences or operations, along with 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 in a fast-paced environment.

Nice To Haves

Advanced degree in Pharmacology, Toxicology, Pharmaceutical Sciences, or a related field.

Responsibilities

Lead Development Sciences Operations activities across programs, including oversight of staff, vendors, and study execution.
Manage and develop direct reports through goal setting, performance management, and coaching.
Serve as the primary operational interface with CROs, establishing workflows, expectations, and oversight.
Manage vendor selection and contracting, including RFIs, SOWs, budgets, and change orders, in partnership with Legal and Finance.
Oversee nonclinical and clinical study execution, ensuring timelines, quality, and compliance with GLP, GCP, and 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 such as IACUC, and internal SOPs.
Drive operational improvements, standardization, and efficiency across Development Sciences activities.