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

hirify.global is a clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine disease targets, including severe hypertriglyceridemia and acromegaly.

What you will do

• Lead the Clinical Data Management function across clinical development programs.
• Provide strategic oversight and hands-on study-level data management from study start-up through database lock and archival.
• Oversee CROs and external vendors, including quality, timelines, deliverables, and resource planning.
• Direct eCRF and clinical database development, edit checks, data cleaning, query management, medical coding, reconciliation, and database lock activities.
• Oversee integration of central laboratory, PK/PD, IRT, eCOA, imaging, and safety data.
• Establish standards, SOPs, governance, quality metrics, systems, and automation while supporting 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.
• Significant Phase 2 and Phase 3 clinical trial experience, preferably in a sponsor environment, including study Data Management Lead responsibilities.
• Strong experience with EDC systems, preferably Medidata Rave, eCRF design, database development, edit checks, data cleaning, external data reconciliation, and database lock.
• Knowledge of GCP, regulatory requirements, CDISC/SDTM, MedDRA, and WHODrug, plus experience with external clinical data.
• Based in South San Francisco and able to work on-site at least three days per week.

Nice to have

• Experience supporting late-stage development, regulatory submissions, audits, and regulatory inspections.
• Advanced degree in a relevant discipline.

Culture & Benefits

• Hands-on role in a collaborative, tight-knit clinical-stage biotechnology environment.
• Opportunity to build and develop the Clinical Data Management function.
• Work closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Pharmacovigilance, Regulatory Affairs, and external partners.