Summary

Direct Biologics is a late-stage biotechnology company headquartered in Austin, Texas, specializing in regenerative medicine through its innovative extracellular vesicle (EV) platform technology. Founded in 2017, the company leverages bone marrow-derived mesenchymal stem cell (BM-MSC) secreted extracellular vesicles to develop therapeutic solutions for multiple disease indications. Their flagship product candidate, ExoFlo, is designed as a scalable and reproducible next-generation biologic that reduces inflammation, modulates the immune system, and promotes tissue regeneration through cellular repair mechanisms. The company operates as a certified cGMP manufacturer and has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its ARDS treatment program. Direct Biologics is currently conducting a global Phase 3 clinical trial for moderate-to-severe acute respiratory distress syndrome (ARDS) and has initiated Phase 1 trials for ulcerative colitis and Crohn's disease, positioning itself as a leader in the rapidly evolving field of regenerative biologics.

Job description

Required Skills

Strong knowledge of FDA regulations and ICH-GCP guidelines
Thorough knowledge of the clinical research process
Strong interpersonal skills with the ability to effectively communicate cross-functionally at all levels of the organization, as well as externally with stakeholders and ESPs
Ability to identify issues and independently assess and recommend specific solutions
Strong organizational skills, prioritization, time management, and cross functional collaboration

Primary Roles and Responsibilities

Successful and timely execution of DM activities and deliverables in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)
Develops and/or approves DM documents (e.g., Data Management Plan, Data Transfer Agreements, Data Review Plans, etc.)
Designs and develops Electronic Data Capture (EDC)
Oversees and coordinates EDC integrations
Develops and maintains standard Case Report Form library
Provides subject matter expertise to the development of other trial documents (e.g., Protocols, Monitoring Plans, Statistical Analysis Plans, Clinical Study Reports, etc.)
Proactively identifies, mitigates, and manages risk in data management issues
Develops and implements DM SOPs in partnership with Clinical Operations and Quality Assurance
Manages DM external service providers (ESPs)
Represents DM in interactions with regulatory authorities, as needed
Applies current industry best practices to DM systems and processes
Leads, trains and mentors DM personnel
Performs other duties as assigned

Qualifications

BA/BS in life sciences relevant field, preferable
10+ years of relevant industry experience
Experience managing department personnel
Experience with relevant EDC systems
Proficiency in Microsoft Office 365

Requirements

Strong knowledge of FDA regulations and ICH-GCP guidelines
Thorough knowledge of the clinical research process
Strong interpersonal skills with the ability to effectively communicate cross-functionally at all levels of the organization, as well as externally with stakeholders and ESPs
Ability to identify issues and independently assess and recommend specific solutions
Strong organizational skills, prioritization, time management, and cross functional collaboration
BA/BS in life sciences relevant field, preferable
10+ years of relevant industry experience
Experience managing department personnel
Experience with relevant EDC systems
Proficiency in Microsoft Office 365

Benefits

Health Insurance
Dental Insurance
Vision Insurance
401(k) Matching
Paid Time Off
Holidays
Stock Options

Company overview

Direct Biologics is a late-stage biotechnology company headquartered in Austin, Texas, specializing in regenerative medicine through its innovative extracellular vesicle (EV) platform technology. Founded in 2017, the company leverages bone marrow-derived mesenchymal stem cell (BM-MSC) secreted extracellular vesicles to develop therapeutic solutions for multiple disease indications. Their flagship product candidate, ExoFlo, is designed as a scalable and reproducible next-generation biologic that reduces inflammation, modulates the immune system, and promotes tissue regeneration through cellular repair mechanisms. The company operates as a certified cGMP manufacturer and has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its ARDS treatment program. Direct Biologics is currently conducting a global Phase 3 clinical trial for moderate-to-severe acute respiratory distress syndrome (ARDS) and has initiated Phase 1 trials for ulcerative colitis and Crohn's disease, positioning itself as a leader in the rapidly evolving field of regenerative biologics.