Director, Business Development – Clinical Trial Technology (Oncology)

Massive Bio•New York, VT

6d•Remote

About The Position

Massive Bio is seeking a Director, Business Development & Client Delivery for SentinelAgent™, its protocol-aware clinical-trial monitoring agent for oncology study close-out. This player-coach role reports to the CEO, with a dotted line to the Chief Medical AI Officer. The position is remote in the United States, with headquarters in Boca Raton, Florida, and requires 25–35% travel. The role has no initial team and is allocated approximately 80% to business development and client delivery and 20% to product support. The Director will sell SentinelAgent™ to oncology sponsors and oversee delivery of sponsor pilots, including ensuring close-out support is documented to standards expected by FDA or EMA inspectors. Responsibilities span sponsor pipeline development, pilot proposals and conversion, contracting, pricing, partner relationships, and compliant close-out support. The role also owns a controlled Site Close-Out Compliance Checklist and works with the QA/Regulatory lead to keep it aligned with applicable requirements. SentinelAgent™ tracks missing records, overdue follow-up, and unresolved queries; pre-fills sponsor EDC entries for authorized site clinicians to review and confirm under their own login; and surfaces open items that delay close-out. It maintains an append-only audit trail built to 21 CFR Part 11 expectations. Sponsor and site teams—not Massive Bio—authorize study closure. The product is contracted, priced, and delivered separately from Massive Bio’s trial-matching and patient-navigation services. The successful candidate has substantial hands-on clinical research data experience, has conducted or hosted close-out visits, and has sponsor-facing business development or account-management experience, including converting at least one pilot into a contract. They should be comfortable with the applicable FDA, EMA/EU, privacy, and clinical-research requirements described in the posting, and with evidence-based selling. The role’s stated 12-month objectives include converting signed pilots into multi-study agreements, achieving zero inspection findings on supported close-outs, and hiring a clinical delivery lead once budget is available.

Requirements

At least 7 years of experience in US clinical research.
Substantial hands-on data-side experience at a site, SMO, or CRO, including CRF entry in a US EDC system as a coordinator or source document verification as a CRA; both are preferred within the stated must-have description.
Experience with Medidata Rave, Oracle Clinical One or InForm, Veeva Vault EDC, or an equivalent EDC system, or comparable source-verification experience.
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 queries, database-lock support, IRB/EC notifications, and retention instructions.
Sponsor-facing business development, alliance, or account-management experience at a CRO, SMO, eClinical vendor, or site network.
At least one pilot converted into a contract.
Working knowledge of the FDA and EMA/EU clinical-research and data-protection framework outlined in the posting, including relevant regulations, guidance, and ICH E6(R3).
Knowledge of site close-out processes, including close-out visit conduct and reporting, investigator site file/TMF reconciliation, delegation log closure, investigational product return or destruction, query resolution, investigator casebook sign-off, database lock, ethics notifications, subject follow-up continuity, and retention and archiving instructions.
Healthcare contracting experience under fair-market-value and anti-kickback constraints, or the judgment to treat the rate card and compliance firewall as essential controls.
Evidence-based selling skills, including use of concordance tables, time-motion studies, and ROI models.

Nice To Haves

Oncology long-term and survival follow-up operations experience.
Experience with RECIST and Schedule of Assessments design.
Ex-US site experience in the UK, EU, Canada, or Australia; Japan exposure, including PMDA or APPI, is also preferred.
ePRO/eCOA operations experience.
Experience as the first commercial hire on a product line.

Responsibilities

Run the business development pipeline with the CEO, target oncology sponsors with post-treatment or long-term follow-up studies, lead study-selection sessions with clinical development, clinical operations, and procurement, and prepare costed pilot proposals within ten business days.
Own sponsor relationships from pilot kickoff through readout, including weekly cadence, gating inputs, readout packages, and conversion of successful pilots into subsequent phases and multi-study agreements.
Prepare and manage engagement documentation, including statements of work under existing master agreements, pilot agreements, vendor qualification, and written agreement on scope, sites, cohort, deliverables, acceptance criteria, and billing rules before work begins.
Price engagements using the approved rate card, apply discount authority within the published schedule, and obtain documented approval for discounts beyond that authority.
Sell study evidence using measures such as concordance with monitor-verified source, staff hours per patient and site, time to resolve missing records and queries, and completed follow-up; evaluate earlier closure and lower site cost as objectives rather than promised results.
Coordinate Massive Bio’s close-out support deliverables for required follow-up, data and queries, safety reconciliation, investigational product accountability, and essential records, with named owners and deadlines.
Ensure required follow-up is completed at the site or continues under an approved transfer; do not waive required follow-up. Put any transferred obligation in writing under 21 CFR 312.52.
Own the Site Close-Out Compliance Checklist as a controlled quality-system document, map it to FDA and EMA requirements, and review it quarterly with the QA/Regulatory lead and after protocol amendments, inspection findings, or regulatory changes.
Develop commercial relationships and agreements with EDC vendors, ePRO/eCOA platforms, and CRO and SMO channels; Product owns technical certification.
Meet weekly with the Product Lead, log sponsor and site requests with persona, source, and date, and communicate those requests to Product, which writes product requirements.
Confirm that EDC pre-fill follows each sponsor’s CRF completion guidelines and that the worklist reflects actual coordinator close-out workflows.
Serve as the site-workflow expert in user acceptance testing before releases; QA owns the validation record.
Bring Regulatory in early when needed and work within healthcare contracting fair-market-value and anti-kickback constraints.