Director, Business Development – Clinical Trial Technology (Oncology)

Responsibilities

The Director will lead business development and client delivery for the SentinelAgent™ platform, targeting oncology sponsors to secure and manage clinical trial pilot programs. They will also act as a product liaison, ensuring site workflows and regulatory compliance standards are met while providing feedback to the product team.

Requirements

Candidates must have 7+ years of experience in US clinical research, specifically in data-side roles such as site coordinator or CRA, with deep knowledge of FDA and EMA regulations. Proven experience in sponsor-facing business development and the ability to manage complex clinical trial contracts are essential.

Skills

• Business Development
• Clinical Trials
• Oncology
• Client Delivery
• FDA Regulations
• EMA Regulations
• Clinical Research Associate
• Electronic Data Capture
• Project Management
• Regulatory Compliance
• Data Management
• Strategic Partnerships
• Proposal Writing
• Account Management
• Site Monitoring
• Quality Assurance

About this role

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
agreement...

About Massive Bio

Hospitals and Health Care · 51-200 employees · headquartered in Istanbul · founded 2019