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About the Role

Massive Bio is transforming how cancer patients discover and access clinical trials by eliminating barriers through an AI-powered precision medicine platform. This role focuses on selling SentinelAgent™ to oncology sponsors and ensuring compliant site closure documentation, reporting directly to the CEO.

Responsibilities

Run the pipeline with the CEO, targeting oncology sponsors for post-treatment or long-term follow-up studies.
Manage the sponsor relationship from kickoff through readout, including weekly cadence, gating inputs, and readout package.
Prepare Statements of Work and pilot agreements, ensuring all clauses (AI-tool, data-use, safety-reporting) are included.
Price engagements using the approved rate card, with documented approval for discounts beyond the published schedule.
Sell evidence-based outcomes such as concordance with source data, staff hours per patient/site, and query resolution times.
Support compliant close-out for all engagements, managing deliverables for follow-up, data, safety reconciliation, and essential records.
Own the Site Close-Out Compliance Checklist as a controlled document, reviewed quarterly and after significant changes.
Build the commercial side of the partner layer, managing relationships with EDC vendors, ePRO/eCOA platforms, and CRO/SMO channels.
Log sponsor and site asks weekly for the Product Lead, contributing to product development.
Confirm EDC pre-fill aligns with sponsor CRF completion guidelines and worklists match site coordinator close-out processes.
Serve as the site-workflow expert during user acceptance testing for product releases.

Requirements

7+ years in US clinical research with significant hands-on data experience at a site, SMO, or CRO.
Experience with CRF entry in a US EDC system (e.g., Medidata Rave, Oracle Clinical One/InForm, Veeva Vault EDC) or source document verification as a CRA.
Experience with query resolution, CRF completion guidelines, and eSource/SDV workflows.
Experience conducting or hosting close-out visits, including essential record reconciliation, investigational product accountability, SAE reconciliation, database lock support, IRB/EC notifications, and retention instructions.
Experience in sponsor-facing business development, alliance, or account management at a CRO, SMO, eClinical vendor, or site network, including converting pilots to contracts.
Working knowledge of FDA and EMA regulatory frameworks.
Experience with healthcare contracting under fair-market-value and anti-kickback constraints.
Proficiency in evidence-based selling using tools like concordance tables, time-motion studies, and ROI models.
Working knowledge of FDA regulations including 21 CFR Part 11, Parts 50 and 56, Part 312, and guidances on electronic source data, EHR data, electronic systems, and risk-based monitoring.
Familiarity with ICH E6(R3), HIPAA, and business associate agreements.
Working knowledge of EMA/EU regulations including Clinical Trials Regulation (EU) 536/2014, EMA guideline on computerized systems, and GDPR.
Understanding of site close-out visit conduct, essential record reconciliation, delegation log closure, investigational product accountability, SAE reconciliation, query resolution, database lock, final IRB/EC notifications, subject follow-up continuity, and retention/archiving instructions.
Awareness of UK clinical trials regulations, Health Canada, and TGA expectations may apply.

Skills

AI-powered precision medicine
Clinical trial discovery and access
Business development
Client delivery
Product support
Sponsor relationship management
Contracting
Regulatory compliance
Data management
Site close-out procedures
Quality systems
Vendor management
User acceptance testing

Location

United States, remote
HQ Boca Raton, FL

Work Type

Remote
Full-time

Experience Level

Director

About the Company

Massive Bio is an AI-powered precision medicine platform transforming how cancer patients discover and access clinical trials.
Founded in 2015 and headquartered in the US, Massive Bio operates globally, connecting patients to clinical trials worldwide.
The company partners with leading pharmaceutical companies, CROs, and healthcare systems to accelerate drug development and expand equitable access to therapies.
Massive Bio is industrializing the oncology action layer, managing the process from trial option confirmation to patient enrollment, monitoring, and close-out.
The product and engineering team is based in Turkiye.
SentinelAgent™ is a protocol-aware monitoring agent on the Reticulum Nexus platform that tracks missing records, overdue follow-up, and unresolved queries to facilitate site close-out.