Director, Clinical Data Management

Denali Therapeutics•South San Francisco, CA

3d•$212,000 - $276,000

About The Position

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. This individual is responsible for leading and overseeing all clinical data management activities across multiple therapeutic areas, ensuring compliance with regulatory standards, and driving process improvements. The role involves strategic leadership, team management, collaboration with cross-functional teams, and the implementation of innovative tools and processes to support the successful execution of clinical trials.

Requirements

BA/BS or higher in math, science, or health-related field; typically requires 10+ years of CDM experience in biotech, pharmaceutical, or health-related industry, including 5+ years of people-management experience.
Strong experience with data standards, EDC systems, and managing vendors/CROs
Thorough knowledge of FDA regulations, ICH-GCP, SDTM, CDISC, database development, UAT, medical coding, and the drug development process
Knowledge of non-CRF data flow/transfer/integration and the DM lifecycle for non-interventional, exploratory, and Phase 1–3 studies (pivotal, blinded, randomized)
Excellent supervisory, problem-solving, negotiation, and organizational skills
Strong team-building and resource-allocation experience

Nice To Haves

Prior experience supporting regulatory submissions, (NDAs, sNDAs,BLAs,) as well as preparing for and supporting regulatory inspections and audits, is strongly preferred.

Responsibilities

Provide leadership and oversight for the execution of clinical data management (CDM) activities across multiple therapeutic areas and molecules. Lead CDM activities at the project or study level, as needed.
Manage a team of Managers and Clinical Data Associates, ensuring effective support for complex data management needs and fostering a productive, skilled workforce. Direct and guide team through DM lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
Drive CDM organizational strategy and lead the implementation of change initiatives, focusing on enhancing processes, systems, and productivity including implementation and maintenance of data standards.
Collaborate with Clinical Programming, Data Science, Clinical Operations, Biostatistics, and other departments to meet project deliverables, ensuring alignment and timely data acquisition.
Lead initiatives to improve data management processes, including recommending new operating procedures and implementing advanced tools to increase efficiency and reduce errors.
Ensure compliance with FDA, EMA, and other global regulatory standards, and lead the preparation of responses to regulatory audits and quality assurance findings.
Anticipate internal resource needs, manage external costs, and work with senior management to ensure long-term resource allocation for data management functions.
Oversee vendor performance and manage the implementation of new systems and tools, including Electronic Data Capture (EDC) systems, to enhance productivity. Ensure the processes, procedures, data deliveries, timelines and study documentation created are of high quality, compliant with study requirements, SOPs, and GCPs.
Lead efforts to address complex issues such as system downtime and vendor performance, ensuring minimal disruption to clinical trial data processes.
Ensure effective communication of functional issues across teams and stakeholders, and lead efforts to communicate changes in priorities or plans clearly and promptly.