AI-Enabled Clinical-Trial Operations Transformation Leader

The mandate

A global biopharmaceutical sponsor dismissed the leader of its clinical-operations transformation after pilot AI tools entered user testing without an agreed validation boundary, traceable human-review controls or reliable integration to trial systems. Study teams have returned to spreadsheets while technology, quality and the implementation partner debate whether protocol intelligence, site selection and monitoring recommendations are decision support or regulated records. The interim leader must take one accountable seat before additional studies adopt inconsistent workarounds or the sponsor loses another operating cycle.

The engagement begins by 28 September 2026 and runs for eight months, five days a week, based onsite in Hyderabad with four planned international governance visits. The first three weeks are a controlled discovery and containment period; the leader will then take the recovery plan through validation, phased study adoption and measured stabilisation. A permanent global process owner is being selected separately and will join during the final month. This is a fixed, non-extendable term, so unresolved discovery cannot be converted into an indefinite transformation programme.

Handover is achieved when the approved AI use cases have documented intended use and risk classification, validation evidence is accepted by Quality, integrations reconcile to the clinical system of record, and at least six studies have operated the revised workflows through two reporting cycles without critical data-integrity deviation. The successor must receive an audit-ready decision trail, accountable model and process owners, monitored thresholds, retraining and change-control rules, a controlled backlog, supplier obligations and quantified cycle-time results against a pre-agreed baseline.

The interim may stop pilot use, set release and validation gates, sequence studies, redeploy transformation capacity inside the approved ₹95 crore envelope, require suppliers to remediate contracted gaps and approve work orders below ₹2 crore. Quality alone approves GxP validation and retains independent authority to reject evidence; medical, safety and clinical leaders remain accountable for patient and scientific decisions. The executive sponsor must approve portfolio reprioritisation, permanent hiring, contract termination, capital above the envelope or adoption in a country not already authorised.

Drug-development strategy, protocol authorship, safety-signal assessment, biostatistical conclusions and replacement of the clinical-trial management system are outside scope. The interim is not being hired to claim that AI can automate investigator judgement or monitoring accountability. The mandate calls for a regulated-change executive who can bring programme control, cloud and integration discipline, multi-country governance and measurable adoption while openly relying on GxP, clinical and validation specialists where domain authority belongs.

Why this seat is open

The previous transformation leader was removed when an internal quality review found that pilot speed had overtaken intended-use definition, validation planning and human accountability. Several active studies now depend on manual bridges, and the next portfolio wave begins within one quarter. The sponsor is recruiting a permanent process owner, but it needs immediate executive control to contain current use, settle the compliant operating model and complete a defined handover within eight months.

What you will own

• Inventory every live and planned AI-assisted clinical workflow, classify its intended use, decision consequence, record status, data sources, accountable human review and current validation position.
• Decide which pilots stop, continue under containment or enter formal validation, documenting the evidence and sponsor approval behind each disposition.
• Establish a traceability chain from protocol and study data through model output, reviewer action, system-of-record update, exception handling and retained audit evidence.
• Direct cloud and clinical-system integrations so identity, access, lineage, versioning, reconciliation, resilience and privacy controls survive both routine operation and vendor change.
• Redesign study adoption around role qualification, monitored human override, site and country readiness, support capacity and benefit baselines rather than licence activation.
• Govern CRO and technology partners against acceptance evidence, defect ageing, validation obligations, data rights and exit provisions, escalating commercial decisions outside delegated limits.
• Induct the permanent owner with accepted validation packs, six-study operating evidence, quantified cycle-time movement, open risks, supplier positions and a governed twelve-month roadmap.

Candidate qualifications

• Led a regulated global technology or operating transformation of at least USD25 million equivalent across multiple countries and accountable control functions.
• Directed cloud migration, platform integration or data-governance change where release evidence had to withstand independent risk, compliance or regulatory scrutiny.
• Recovered a stalled programme by separating mandatory control remediation from longer-term product ambition and restoring an evidence-based governance cadence.
• Demonstrates material exposure to GxP, clinical operations, regulated life sciences or validated computerized systems; general financial regulation alone is insufficient.
• Understands validated AI principles including intended use, data lineage, human oversight, model versioning, monitoring, change control and reproducible evidence.
• Has led global teams and strategic suppliers through adoption, not merely technical delivery, and can quantify cycle-time, quality or conversion outcomes from the change.

Non-negotiables

• Available to start by 28 September 2026, work onsite in Hyderabad five days weekly and complete four planned international governance visits.
• Will not claim clinical, medical, safety or GxP authority that belongs to qualified accountable specialists and will make any domain gap explicit.
• Has personally stopped or contained a regulated technology release when evidence, validation or operational readiness did not support deployment.
• Accepts the eight-month fixed term, final-month successor handover and no-extension condition without seeking conversion to the permanent seat.

1. 49 words maximum. State your earliest start date and the regulated technology release you stopped or contained because validation or control evidence was inadequate.
2. 49 words maximum. What direct GxP, clinical-operations or validated-system experience do you have, and which clinical domain decisions would you leave to accountable specialists?
3. 49 words maximum. How would you prove that an AI-assisted trial workflow is traceable, human-controlled and ready for adoption across six studies?