DIRECTOR, CLINICAL DATA MANAGEMENT

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

Director, Clinical Data Management

Position Summary

The Director, Clinical Data Management leads the clinical data management function across Sutro Biopharma's development portfolio. This role sets the strategy, standards, and operating approach for collecting, reviewing, and delivering reliable clinical data that support patient safety, development decisions, and regulatory submissions.

In a lean clinical-stage organization, the Director is accountable for data management deliverables across assigned studies and programs, provides direct oversight of CROs and technology partners, and serves as the senior internal expert on clinical data systems and data integrity. The role combines portfolio-level leadership with hands‑on review of critical study designs, data issues, and database readiness. It partners closely with Clinical Development, Clinical Operations, Biostatistics, Statistical Programming, Pharmacovigilance, Clinical Pharmacology, Translational Sciences, and Regulatory Affairs.

Key Responsibilities

Function and Portfolio Leadership

• 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.

Study Execution and Data Quality

• Oversee data management from protocol development and study start-up through database design, study conduct, interim data cuts, database lock, and archival.
• Approve fit-for-purpose data management plans, eCRFs, completion guidelines, EDC specifications, edit checks, user acceptance testing, change control, and database validation deliverables.
• Direct risk-based data review and cleaning strategies; monitor completeness, consistency, query aging, data related to protocol deviations, and readiness for safety review, dose escalation, and analyses.
• Lead cross-functional planning and decision-making for interim data cuts, freezes, and final locks; define lock criteria and confirm that critical issues, reconciliations, and approvals are documented.
• Oversee specifications, receipt, integration, and reconciliation of laboratory, PK, biomarker, imaging, ECG, eCOA, IRT, and other external data as applicable, including serious adverse event reconciliation with the safety database.

CRO and Vendor Governance

• Own operational and technical oversight of outsourced CDM services and EDC or external data providers; set deliverable, documentation, communication, and escalation expectations.
• Lead the CDM evaluation of vendors, scopes of work, timelines, resource plans, performance measures, and change orders; provide input on budgets and contracting decisions.
• Chair or lead vendor governance discussions, review performance and data quality trends, and drive remediation of service or compliance issues while retaining clear sponsor oversight.

Systems Standards and Compliance

• Own CDM SOPs, work instructions, templates, data standards, and inspection-ready documentation; promote appropriate CDISC alignment, including CDASH and downstream SDTM needs.
• Evaluate and improve EDC, external data, review, and reporting tools; partner with stakeholders on clinical data governance, integrations, and practical automation.
• Ensure CDM work complies with applicable regulatory requirements, ICH/GCP, company procedures, and data integrity expectations; support audits, inspections, submissions, health authority responses, deviations, and CAPAs as appropriate.

Qualifications

Bachelor’s degree in life sciences, statistics, computer science, health sciences, or a related field; advanced degree is a plus.

• Approximately 10 or more 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