Director of Clinical Data Management & Data Integrity

Sutro Biopharma, Inc.; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sutro Biopharma, Inc. seeks a Director of Clinical Data Management to lead the CDM function across the development portfolio.

This role defines strategy, standards, and operating models for collecting and delivering reliable clinical data to support safety, development decisions, and regulatory submissions. In a lean organization, the Director oversees CROs and technology partners, and serves as the senior expert on data systems and data integrity.

Qualifications

• Approximately 10+ years of progressive clinical data management experience in biotechnology, pharmaceuticals, or a CRO, including leadership of multiple complex studies or programs and oversight of outsourced delivery.
• Demonstrated ability to set CDM strategy and standards, manage priorities across studies, and influence clinical and technical partners at the program level.
• Deep experience with EDC design and validation, data review and cleaning, external data transfers and reconciliation, interim data cuts, and database lock.
• Strong knowledge of ICH/GCP, clinical data integrity, and CDISC standards, including CDASH and SDTM; experience supporting regulatory submissions or inspections preferred

Responsibilities

• Own the clinical data management strategy, priorities, and delivery across the portfolio; align study plans, resources, timelines, and quality expectations with program milestones.
• Serve as the accountable CDM lead on clinical and program teams, advise on protocol design and endpoint data collection, and escalated material data risks with clear options and recommendations.
• Build scalable CDM standards, governance, processes, and oversight practices suited to an expanding early-stage oncology portfolio; establish consistent quality metrics and reporting.
• Plan internal and external CDM capacity, assess capability gaps, and mentor team members and external partners as the function evolves.
• Oversee data management from protocol development and study start-up through database design, study conduct, interim data cuts, database lock, and archival.

Skills

CDM leadership

EDC design

Data quality

Regulatory submissions

CDISC standards

ICH/GCP

Vendor governance

Data integrity

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Job description

Sutro Biopharma, Inc. seeks a Director of Clinical Data Management to lead the CDM function across the development portfolio.

This role defines strategy, standards, and operating models for collecting and delivering reliable clinical data to support safety, development decisions, and regulatory submissions. In a lean organization, the Director oversees CROs and technology partners, and serves as the senior expert on data systems and data integrity.