Senior Director, Clinical Data Management & Strategy

Protego Bio; San Diego (CA); Hybrid; USD 200,000 - 235,000; Full time

Benefits offered by this job

Incentive stock option plan

401k plan with employer contribution

Dental and vision insurance

HSA, FSA, and supplemental insurance

Job summary

Protego Bio is a San Diego-based clinical-stage biotechnology company developing first-in-class small-molecule therapeutics targeting protein misfolding diseases. The incumbent will oversee Data Management activities ensuring compliance with CRO/CDM timelines and work scope, while aligning with regulatory expectations.

The role demands extensive CDM leadership, CST design, data standardization (CDISC SDTM/ADaM), and coordination with Biostatistics, Regulatory Affairs, and IT.

Qualifications

• BS in Life Sciences, Computer Sciences or Mathematics and 12+ years of related experience.
• 15+ years combined data management and leadership experience is preferred.

Responsibilities

• Provide end-to-end operational leadership for all CDM activities including study design, CRF development, database build, data cleaning, reconciliation and database lock.
• Define and execute the CDM strategy aligned with timelines, regulatory requirements and pipeline priorities.
• Build and scale a high-performing CDM function with SOPs and standards for a growing clinical program.
• Champion process improvements using risk-based monitoring and quality-by-design.
• Lead vendor evaluation, qualification, selection, and oversight for CROs and tech partners providing CDM services.

Skills

CDM leadership

EDC platforms

SAS programming

CDISC SDTM

ADaM Define.xml

FDA/ICH GCP knowledge

data governance

Tableau/Power BI

cross-functional collaboration

vendor management

Education

BS in Life Sciences / Computer Sciences / Mathematics

12+ years data management in pharma/biotech

MS or PhD preferred

Tools

Medidata Rave

Veeva Vault EDC

Oracle InForm/Clinical One

Pinnacle 21

Tableau / Power BI / JMP

Job description

Protego Bio is a San Diego-based clinical-stage biotechnology company developing first-in-class small-molecule therapeutics targeting protein misfolding diseases. The incumbent will oversee Data Management activities ensuring compliance with CRO/CDM timelines and work scope, while aligning with regulatory expectations.

The role demands extensive CDM leadership, CST design, data standardization (CDISC SDTM/ADaM), and coordination with Biostatistics, Regulatory Affairs, and IT.