Director, Clinical Data Management

Denali Therapeutics; South San Francisco (CA); Vor Ort; USD 212.000 - 276.000; Vollzeit

Zusammenfassung

Denali Therapeutics is seeking a Senior Director of Clinical Data Management to lead CDM activities across multiple therapeutic areas and manage a team of managers and CDAs. You will drive data standards, vendor management, and use of EDC systems while ensuring FDA/EMA regulatory compliance and high-quality data delivery for pivotal trials.

The role requires 10+ years in CDM with 5+ years of people management, strong problem-solving, and collaboration with cross-functional teams to optimize

Qualifikationen

• BA/BS or higher in math, science, or health-related field with 10+ years of CDM experience.
• Minimum 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, and the drug development process.
• Experience supporting regulatory submissions and audits is preferred.

Aufgaben

• Lead CDM activities across multiple therapeutic areas and molecules.
• Manage a team of Managers and Clinical Data Associates.
• Drive CDM strategy and implementation of new data standards and tools.
• Ensure compliance with FDA/EMA regulatory standards and audits.
• Oversee vendor performance and EDC system implementations.

Kenntnisse

CDM leadership

Vendor management

Regulatory knowledge

Data standards

EDC systems

Team leadership

Ausbildung

BA/BS in science/health

Tools

EDC systems

Jobbeschreibung

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.

Key Accountabilities / Core Job 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.

Qualifications/Skills

• 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

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

• 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

Salary Range: $212,000.00 to $276,000.00 .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.