Director, Clinical Data Management

Our client is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond WA and Princeton NJ. It specializes in developing innovative cancer treatments using its established drug development platforms focusing on bi-specific multi-specific antibodies and antibody-drug conjugates (ADCs). Our client has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. Our client has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the companys success. Our client is seeking an experienced and strategic Director Clinical Data Management to lead the clinical data management function across our portfolio. This individual will be responsible for overseeing all aspects of clinical data management activities from study start-up through database lock and regulatory submission. The Director will provide leadership for internal and external data management teams ensure high-quality and inspection-ready clinical data and contribute to the development and execution of data management strategies supporting global clinical trials. The successful candidate will collaborate closely with Clinical Operations Biostatistics Statistical Programming Clinical Development Pharmacovigilance Regulatory Affairs and external partners to ensure timely and compliant delivery of clinical data for decision-making and regulatory submissions. This position is full-time onsite and can work out of our Redmond WA or Princeton NJ locations. Responsibilities

Lead and oversee the Clinical Data Management function including strategy standards processes and operational execution across the development portfolio.

Build and scale a high-performing data management infrastructure to support a growing clinical pipeline.

Serve as a key cross-functional leader in clinical development planning and execution.

Oversee all data management activities for Phase IIII clinical trials from study start-up through database lock and regulatory submission.

Ensure the delivery of high-quality complete and reliable clinical data through effective data review issue management and quality oversight.

Drive timely database lock and submission-ready data deliverables in accordance with study timelines.

Ensure compliance with ICH-GCP FDA EMA and other applicable regulatory requirements while maintaining inspection readiness.

Establish and maintain CDISC-compliant data standards and industry best practices to support regulatory submissions.

Collaborate closely with Clinical Operations Biostatistics Statistical Programming Medical Monitoring and Safety teams to support study execution data review and submission readiness.

Qualifications

Bachelors degree in Life Sciences Computer Science Statistics or a related field required; Masters degree preferred.

Minimum 10 years of clinical data management experience within the pharmaceutical biotechnology or CRO industry.

At least 5 years of leadership experience managing data management teams vendors and CRO partnerships.

Significant experience supporting oncology clinical trials across early- and late-stage development.

Demonstrated experience supporting regulatory submissions (NDA BLA MAA) and health authority inspections.

Expertise with EDC systems external data integrations data reconciliation and database management.

Strong knowledge of clinical trial databases CDISC standards coding dictionaries (e.g. MedDRA WHO Drug) and clinical data workflows.

Familiarity with risk-based quality management principles GCP requirements and clinical development processes.

Working knowledge of biostatistics statistical analysis and clinical data reporting to support cross-functional collaboration.

Proven leadership strategic thinking problem-solving communication and stakeholder management skills with a track record of driving cross-functional collaboration and operational excellence in a fast-paced biotech environment.

Preferred Qualifications

Oncology and/or antibody-drug conjugate (ADC) development experience.

Experience managing global clinical trials across multiple regions.

Prior experience in a growing biotechnology company.

Compensation and Benefits: The expected base salary range for this position is $190000 - $250000 annually. Actual compensation will be based on a variety of factors including but not limited to a candidates level qualifications experience and skills.