Senior Director, Data Management (Clinical Data Management)

Location: South San Francisco, United States; on-site at least three days per week

Salary: $250,000–$300,000 per year

Company

Clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine disease targets, including programs for severe hypertriglyceridemia and acromegaly.

What you will do

• Lead the Clinical Data Management function across clinical development programs and provide strategic and operational direction.
• Serve as a hands-on study Data Management Lead when needed, overseeing activities from study start-up through database lock and archival.
• Manage CROs and external data management vendors, including quality, timelines, deliverables, and operational risks.
• Oversee eCRFs, clinical databases, Data Management Plans, edit checks, data cleaning, query management, medical coding, reconciliation, and database lock.
• Establish data management standards, SOPs, governance, quality metrics, and fit-for-purpose systems and automation.
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Pharmacovigilance, Regulatory Affairs, and external partners to support analyses, submissions, audits, and inspections.

Requirements

• Bachelor’s degree in life sciences, health sciences, computer science, or a related field; an advanced degree is preferred.
• 15+ years of progressive clinical data management experience in biotechnology, pharmaceutical, or CRO environments.
• Experience leading Phase 2 and Phase 3 clinical trial data management, preferably in a sponsor environment.
• Hands-on experience with EDC systems, preferably Medidata Rave, eCRF design, database development, edit checks, data cleaning, external data reconciliation, and database lock.
• Strong knowledge of GCP, regulatory requirements, CDISC/SDTM, MedDRA, WHODrug, and clinical data management standards.
• Ability to work on-site in South San Francisco at least three days per week.

Nice to have

• Experience supporting late-stage development, regulatory submissions, audits, and regulatory inspections.
• Experience managing central laboratory, PK/PD, eCOA, IRT, imaging, and safety data.
• Advanced degree in a relevant field.

Culture & Benefits

• Hands-on, collaborative environment with close interaction across functions and levels.
• Opportunity to build and develop the Clinical Data Management function, including resource planning and vendor strategy.
• Responsibility for mentoring internal staff and consultants in a growing biotechnology company.