Director, Business Development – Clinical Trial Technology (Oncology)

About Massive Bio

Every cancer patient deserves access to treatment options. Massive Bio is an AI-powered precision medicine platform transforming how cancer patients discover and access clinical trials by eliminating the barriers of geography, financial constraints, and information asymmetry that have historically limited enrollment.

Founded in 2015 and headquartered in US, Massive Bio is scaling its impact globally by powering operations across multiple countries and bringing innovative cancer treatment options to a rapidly growing and diverse population of patients. Through our proprietary AI platform, we connect individuals to clinical trials worldwide and partner with leading pharmaceutical companies, contract research organizations (CROs), and healthcare systems to accelerate drug development and expand equitable access to cutting-edge therapies.

Director, Business Development & Client Delivery, SentinelAgent™

You sell SentinelAgent™ to oncology sponsors, then make sure every site closure it supports is documented to the standard an FDA or EMA inspector expects. Both halves are yours.

Location: United States, remote (HQ Boca Raton, FL) · Reports to: CEO · Level: Director · Travel: 25–35%

The role

You report to the CEO, with a dotted line to the Chief Medical AI Officer. About 80% of your week is business development and client delivery. The other 20% is product support: bringing what sponsors and sites tell you to the product team, and checking that what we ship matches how a study coordinator actually works a close-out.

This seat exists because sponsor pilots are under way and the next wave needs to be sold, papered and delivered by someone who has worked on the data side. You have entered case report form (CRF) data in a US electronic data capture (EDC) system as a coordinator, or source-verified it as a monitor, and ideally both. You have conducted close-out visits as a CRA or hosted them as the site coordinator. Then you moved into sponsor-facing business development. If none of that describes you, this is not the seat.

It is a player-coach seat with no team to start. You write the proposals, run the sponsor cadence and sit in the close-out reviews yourself. Twelve months out, the picture is a pipeline of signed pilots converting into multi-study agreements, zero inspection findings on any close-out we supported, and the budget to hire a clinical delivery lead. You hire them.

What you'll do

Business development and client delivery (80%)

• Run the pipeline with the CEO. Target oncology sponsors with studies in post-treatment or long-term follow-up, run the "select a study" session with clinical development, clinical operations and procurement, and turn it into a costed pilot proposal within ten business days.

• Convert pilots. Own the sponsor relationship from kickoff through readout: the weekly cadence, the gating inputs (consent language, Schedule of Assessments, EDC access, site-entered comparison data) and the readout package. Turn the result into the next phase and a multi-study agreement.

• Paper every engagement correctly. Statements of work under existing master agreements, including each sponsor's AI-tool, data-use and safety-reporting clauses; pilot agreements and vendor qualification for new partners. Scope, sites, cohort, deliverables, acceptance criteria and billing rules are agreed in writing before work begins.

• Price off the approved rate card. You have discount authority within a published schedule; anything beyond it goes through a documented approval. Fees are for services rendered and never depend on patient referral, recruitment, enrollment or site-selection outcomes.

• Sell the evidence. Concordance with monitor-verified source, staff hours per patient and per site, days to resolve missing records and queries, follow-up completed. Earlier closure and lower site cost are objectives we evaluate on each study, not results we promise.

• Support compliant close-out on every engagement. Run Massive Bio's close-out support deliverables across required follow-up, data and queries, safety reconciliation, investigational product accountability and essential records, with named owners and deadlines. The sponsor's monitor conducts the close-out visit and the sponsor authorizes closure; any obligation we take on is transferred in writing under 21 CFR 312.52. Required follow-up is completed at the site or continues under an approved transfer. It is never waived.

• Own the Site Close-Out Compliance Checklist as a controlled document in our quality system, mapped to FDA and EMA requirements and reviewed quarterly with our QA/Regulatory lead and after every protocol amendment, inspection finding or regulatory change.

• Build the commercial side of the partner layer: EDC vendors, ePRO/eCOA platforms, and CRO and SMO channels. Product owns the technical certification; you own the relationship and the paper.

Product support (20%)

• A weekly hour with the Product Lead. Every sponsor and site ask is logged with persona, source and date. You bring the asks; Product writes the requirements.

• Confirm that EDC pre-fill follows each sponsor's CRF completion guidelines and that the worklist matches how a coordinator actually works a close-out.

• Serve as the site-workflow expert in user acceptance testing before each release. QA owns the validation record.

The compliance bar

Sponsors, counsel and inspectors will test you on this, so you need working knowledge of:

• FDA: 21 CFR Part 11; Parts 50 and 56; Part 312 sponsor and investigator obligations, including monitoring, record-keeping and retention; the guidances on electronic source data (2013), use of EHR data in clinical investigations (2018), electronic systems, records and signatures (2024 Q&A) and risk-based monitoring; ICH E6(R3); HIPAA and business associate agreements for site data.

• EMA / EU: Clinical Trials Regulation (EU) 536/2014, including end-of-trial notification and 25-year trial master file retention; ICH E6(R3); the EMA guideline on computerised systems and electronic data in clinical trials; GDPR for site data.

• At the site: close-out visit conduct and report; essential-record reconciliation between the investigator site file and the TMF; delegation log closure; investigational product accountability and return or destruction; SAE reconciliation queries; query resolution, investigator casebook sign-off and database lock; final IRB and ethics-committee notifications; continuity of subject follow-up; retention and archiving instructions.

Studies we support can include ex-US sites, so UK clinical trials regulations, Health Canada and TGA expectations may apply as well.

What you bring

Must have

• 7+ years in US clinical research, with substantial hands-on time on the data side at a site, SMO or CRO: CRF entry in a US EDC (Medidata Rave, Oracle Clinical One or InForm, Veeva Vault EDC or equivalent) as a coordinator, or source document verification as a CRA, and ideally both; query resolution; CRF completion guidelines and eSource/SDV workflows from the inside.

• Close-out visits you conducted or hosted: essential-record reconciliation, investigational product accountability, SAE reconciliation queries, database-lock support, IRB/EC notifications, retention instructions.

• Sponsor-facing business development, alliance or account management at a CRO, SMO, eClinical vendor or site network, with at least one pilot you turned into a contract.

• Working knowledge of the FDA and EMA frame above, and the instinct to bring in Regulatory early.

• Healthcare contracting under fair-market-value and anti-kickback constraints, or the judgment to treat the rate card and the compliance firewall as load-bearing walls.

• Evidence-based selling: a concordance table, a time-motion study and an ROI model carry your meetings.

Nice to have

• Oncology long-term and survival follow-up operations; RECIST; Schedule of Assessments design.

• Ex-US site experience (UK, EU, Canada, Australia) and Japan exposure (PMDA, APPI).

• ePRO/eCOA operations.

• You have been the first commercial hire on a product line before, and liked it.

If you have the close-out experience and the selling but not every regulation on the list, apply anyway.

About SentinelAgent™

Massive Bio is industrializing the oncology action layer: taking a cancer patient from a clinician-confirmed trial option to an enrolled, monitored participant, and now to the follow-up, data, safety and records work that lets a site close on time. We are headquartered in Boca Raton, Florida, our product and engineering team is in Turkiye, and we work with leading oncology sponsors in the United States, Europe and Asia.

SentinelAgent™ is our protocol-aware monitoring agent on the Reticulum Nexus platform. It tracks missing records, overdue follow-up and unresolved queries in one worklist, pre-fills the sponsor's EDC entry for an authorized clinician at the site to review and confirm under their own login before anything is submitted, and surfaces the open items delaying close-out for sponsor and site teams to act on. Every action sits on an append-only audit trail built to 21 CFR Part 11 expectations, and sponsor and site teams, never Massive Bio, authorize closure. SentinelAgent™ is contracted, priced and delivered separately from Massive Bio's trial-matching and patient-navigation services.