Director, Clinical Data Management

About the Company

Protego Bio is a clinical-stage biotechnology company based in San Diego, California, focused on developing first-in-class small-molecule therapeutics that target protein misfolding diseases. By restoring protein stability and function through novel pharmacological chaperones, Protego aims to transform the treatment of rare and systemic diseases with significant unmet medical need.

Protego's lead program is being developed for AL amyloidosis and builds upon the clinically validated pharmacological chaperone approach pioneered by our cofounders, Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, whose work led to the discovery and development of tafamidis for transthyretin amyloidosis (ATTR).

About the job

The incumbent will be responsible for oversight of all Data Management operational activities ensuring compliance with the corporate timeline and scope of work outsourced to Clinical CRO or CDM Contract Research Organizations.

Essential Functions And Responsibilities

Operational & Strategic Leadership

• 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 corporate timelines, regulatory requirements, and pipeline priorities.
• Build and scale a high-performing CDM function, establishing processes, SOPs, and standards that support a growing clinical program.
• Champion continuous process improvement initiatives, incorporating risk-based monitoring principles and quality-by-design frameworks.

Vendor & Technology Management

• Lead vendor evaluation, qualification, selection, and oversight for all CRO and technology partners providing CDM services.
• Manage RFP development, contract negotiations, budgets, and ongoing performance management of CDM vendors.
• Oversee implementation and governance of Electronic Data Capture (EDC) systems (e.G., Medidata Rave, Veeva Vault EDC, Oracle Clinical) and associated clinical data technologies.
• Evaluate and integrate new data collection tools including ePRO/eCOA, IWRS, central lab, and imaging platforms

Data Governance & Quality

• Develop, review, and approve study-specific Data Management Plans (DMPs), CRF Completion Guidelines, edit check specifications, coding guidelines, and annotated CRFs.
• Ensure clinical databases and external data transfers are designed in a standardized, consistent, and analysis-ready format compliant with CDISC SDTM and ADaM standards.
• Oversee medical coding activities using MedDRA and WHO Drug dictionaries, ensuring timely and accurate coding.
• Coordinate data review, reconciliation, and resolution of data discrepancies across clinical, safety, and third-party data sources.
• Ensure all databases are of sufficient quality for lock and submission, supporting regulatory filings including INDs, NDAs, BLAs, and MAAs. Cross-Functional Collaboration
• Partner with Biostatistics to ensure datasets are structured for efficient statistical analysis and TLF production.
• Collaborate with Clinical Operations, Regulatory Affairs, Drug Safety, and IT on data flow, integration, and system validation.
• Represent CDM in project team meetings, governance committees, and regulatory interactions.
• Train investigators, site staff, as needed.

Required Education, Experience, Skills, And Abilities

• Position requires a BS in a Life Sciences, Computer Sciences or Mathematics field of study and a minimum of 12 years of related experience, with at least 5 years of data management experience in the pharmaceutical or biotechnology industry, and at least 5 years of people management experience. (MS, PhD) preferred.
• Prior clinical trial responsibility for the entire data management life cycle is also required.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• In-depth knowledge of CDISC standards (SDTM, ADaM, Define.Xml) and Pinnacle 21 validation tools.
• Proficiency with major EDC platforms (e.G., Medidata Rave, Veeva Vault EDC, Oracle InForm/Clinical One).
• Working knowledge of ICH E6 GCP, FDA 21 CFR Parts 11 and 312, and EMA regulatory requirements.
• Strong understanding of medical coding dictionaries: MedDRA and WHO Drug.
• Competency in Microsoft Office suite (Word, Excel, PowerPoint, Project).
• Familiarity with data visualization tools such as Tableau, Power BI, or JMP Clinical to support operational analytics and study dashboards.
• Familiarity with SAS programming or SAS-based data review tools commonly used in biostatistics environments is a plus.
• Understanding of data management technology, software languages and computer systems.
• Sound knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Ability to work in and effectively contribute to cross-functional teams in face-to-face conversation, by telephone, and by email.
• Excellent verbal/written and interpersonal skills.
• Ability to create strong, collaborative working relationships and encourage creative solutions by effectively working through conflicts.
• Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.
• Occasional travel may be required

Salary Range: $200,000 - $235,000 a year

In addition to a competitive base salary, we offer stock options and a target bonus. Protego also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.

Please note that the salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.

Job Type: Full-time

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with employer contribution
• Comprehensive medical insurance
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans
• Paid Time Off
• Company paid holidays

Schedule

• Monday to Friday

Work Authorization

• United States (Required)

Work Location

• Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 10% for meetings or site visits as required.

Equal Opportunity Employer

Protego Bio, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.