Director, Clinical Data Management — Data Strategy Lead

Xencor; San Diego (CA); Híbrido; USD 195 000 - 240 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401k match

Healthcare coverage

ESPP

Equity grant

Annual bonus

Resumo da oferta

Xencor, a hybrid biopharmaceutical company with offices in Pasadena and San Diego, seeks a Director, Clinical Data Management. This role offers a hybrid schedule with two onsite days per week in San Diego and leads all DM operations to ensure data quality and regulatory readiness.

You will manage CROs, develop DM standards, coordinate data delivery for submissions, and mentor a DM team. Requirements include a BS in life sciences/CS/Math, 12+ years in pharma/biotech DM, 5+ years of people

Qualificações

• BS in Life Sciences, Computer Sciences or Mathematics and 12+ years in pharma/biotech data management.
• At least 5 years of data management and 5 years of people management experience.
• Experience overseeing DM life cycle and external CROs.
• Strong knowledge of ICH, FDA, and GCP.
• Proven leadership and cross-functional collaboration.

Responsabilidades

• Provides operational leadership to data management across studies.
• Oversees vendor evaluation, budgeting, contract negotiations for DM services.
• Builds and maintains DM vendor relationships and supports RFPs.
• Develops study-specific DM documentation (DM plan, CRF guidelines, edit checks).
• Ensures databases and external data files are design-standards compliant for regulatory submission.
• Reviews data, tables, listings for consistency and accuracy.
• Ensures high-quality data for review and analysis.

Conhecimentos

Data management leadership

DM life cycle

People management

Clinical trials

Regulatory knowledge

Cross-functional teamwork

Communication

CDISC/STDM/MeDRA

Formação académica

BS in Life Sciences/CS/Math

Ferramentas

EDC systems

Data management software

Descrição da oferta de emprego

Xencor, a hybrid biopharmaceutical company with offices in Pasadena and San Diego, seeks a Director, Clinical Data Management. This role offers a hybrid schedule with two onsite days per week in San Diego and leads all DM operations to ensure data quality and regulatory readiness.

You will manage CROs, develop DM standards, coordinate data delivery for submissions, and mentor a DM team. Requirements include a BS in life sciences/CS/Math, 12+ years in pharma/biotech DM, 5+ years of people