Business Development & Client Delivery Manager

Massive Bio•Boca Raton, FL

4d•Remote

About The Position

Massive Bio is seeking a player-coach to lead business development and client delivery for SentinelAgent™, its protocol-aware monitoring agent for oncology clinical-trial close-out work. The Director will sell the product to oncology sponsors and ensure supported site closures are documented to standards expected by FDA and EMA inspectors. The role is remote in the United States, reports to the CEO with a dotted line to the Chief Medical AI Officer, and involves 25–35% travel. The role begins without a team; the Director will personally write proposals, manage sponsor relationships and participate in close-out reviews, with the goal of hiring a clinical delivery lead after building a pipeline and securing the budget. Approximately 80% of the role is business development and client delivery, and 20% is product support. The Director will develop sponsor opportunities, turn study-selection discussions into costed pilot proposals, convert pilots into multi-study agreements, manage contracts and vendor qualification, and oversee the delivery and readout of engagements. The role also owns Massive Bio’s close-out support deliverables and a controlled Site Close-Out Compliance Checklist, working with the QA/Regulatory lead. Fees are for services rendered and cannot depend on patient referral, recruitment, enrollment or site-selection outcomes. Product support includes bringing documented sponsor and site feedback to the Product Lead and serving as a site-workflow expert in user acceptance testing; Product owns requirements and QA owns validation records. The position requires substantial hands-on clinical research experience on the data side, close-out experience, and sponsor-facing business development or account management experience. The successful candidate should have working knowledge of relevant FDA, EMA/EU, ICH, HIPAA and GDPR requirements and be able to involve Regulatory early. Massive Bio’s SentinelAgent™ tracks missing records, overdue follow-up and unresolved queries, and can pre-fill EDC entries for an authorized site clinician to review and submit under their own login. Sponsor and site teams—not Massive Bio—authorize closure.

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; ideally both.
Experience resolving queries and working with 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, including at least one pilot converted into a contract.
Working knowledge of the FDA and EMA/EU regulatory framework described in the posting, and judgment to involve Regulatory early. This includes relevant FDA regulations and guidance, ICH E6(R3), HIPAA and business associate agreements, EU Clinical Trials Regulation and GDPR.
Knowledge or sound judgment concerning healthcare contracting under fair-market-value and anti-kickback constraints, including adherence to the rate card and compliance firewall.
Ability to sell using evidence such as concordance tables, time-motion studies and ROI models.
Ability to manage sponsor relationships, proposals, contracting, delivery and close-out reviews as an individual contributor in a player-coach role.
Availability for 25–35% travel.

Nice To Haves

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

Responsibilities

Run the business-development pipeline with the CEO and target oncology sponsors with studies in post-treatment or long-term follow-up.
Lead study-selection sessions with clinical development, clinical operations and procurement, and deliver a costed pilot proposal within ten business days.
Own sponsor relationships from kickoff through readout, including weekly cadence, gating inputs and readout packages; convert successful pilots into subsequent phases and multi-study agreements.
Prepare statements of work under existing master agreements and handle pilot agreements and vendor qualification for new partners, addressing sponsor-specific AI-tool, data-use and safety-reporting clauses.
Ensure scope, sites, cohort, deliverables, acceptance criteria and billing rules are agreed in writing before work begins; price according to the approved rate card and document approvals for discounts outside the published schedule.
Sell evidence using measures such as concordance with monitor-verified source, staff hours per patient and site, time to resolve missing records and queries, and follow-up completion; treat earlier closure and lower site cost as objectives rather than promised results.
Run close-out support deliverables for each engagement, covering required follow-up, data and queries, safety reconciliation, investigational product accountability and essential records, with named owners and deadlines.
Ensure sponsor-monitor and sponsor-authorization responsibilities are respected, obligations are transferred in writing where applicable under 21 CFR 312.52, and required follow-up is completed or continues under an approved transfer rather than waived.
Own and maintain the Site Close-Out Compliance Checklist as a controlled quality-system document mapped to FDA and EMA requirements; review it quarterly with the QA/Regulatory lead and after protocol amendments, inspection findings or regulatory changes.
Develop commercial relationships with EDC vendors, ePRO/eCOA platforms, CROs and SMO channels; Product owns technical certification while this role owns relationships and contracting.
Log sponsor and site requests with persona, source and date, and bring them to the Product Lead in a weekly meeting; Product writes product requirements.
Confirm EDC pre-fill follows sponsor CRF completion guidelines and that the worklist reflects actual coordinator close-out workflows.
Serve as the site-workflow expert in user acceptance testing before each release; QA owns the validation record.
Build the pipeline of signed pilots, convert them into multi-study agreements, support inspection-ready close-outs and, when the budget is available, hire a clinical delivery lead.