Oncology-Trial Comparator-Sourcing Director

The mandate

Eleven oncology trials forecast comparator demand from enrolment but source it through local wholesalers, manufacturer programmes and brokers with different evidence and lead times. A globally available medicine may have unsuitable pack, short expiry, country restrictions or a batch mix that cannot support blinding and resupply. Recent emergency buys preserved site stock but left origin and price chains difficult to reproduce. The defined problem is a controlled sourcing architecture from authorised product to protocol-ready supply, not a purchasing event or trial-design review.

The deliverable is a comparator sourcing book containing product and market identities, approved source archetypes, authenticity and trading evidence, batch and expiry controls, demand confidence, overage, repack and blinding windows, import pathways, depot placement, resupply triggers, recall reach and exception authority. Twelve historic buys and five live sourcing decisions form the casebook. Supplier award, legal opinion, product release, clinical protocol, randomisation and dispensing are excluded.

Milestone one, at week two, reconciles trial, demand, stock, source and twelve historic case populations. Milestone two, at week five, delivers source, authenticity, expiry and country decision rules. Milestone three, at week nine, pilots five live sourcing decisions and one batch-recall trace. Milestone four, at week twelve, submits the accepted sourcing book, evidence packs, owner training and 120-day remediation backlog.

Acceptance requires Clinical Supply, Quality, Regulatory and sourcing owners to reproduce product, authorised origin, seller chain, batch, expiry, pack, repack window, import eligibility and trial demand for each pilot decision. Five cases must remain viable under a 30% enrolment change without unsafe expiry or untraceable spot substitution. The council accepts when a recall reaches every affected depot and kit population and permanent teams apply source tiers unaided.

The client will provide protocols and authorised product requirements, enrolment scenarios, inventory, batch and expiry, prior purchases, supplier files, licences, pedigree, prices, packaging plans, country permissions, depot data and deviations. It will nominate Trial Supply, Quality and Regulatory owners, secure eight reviews and make live sourcing cases available. Management retains supplier selection, purchase, trial, product-release, import and patient-use authority.

Why this is external work

Trial teams protect enrolment, sourcing teams protect availability and Quality protects product evidence, but no shared method values time lost to pack, expiry and country conversion. Incumbent brokers cannot neutrally design source tiers that may exclude them. Independent comparator expertise can make five real decisions quickly without taking contract or clinical authority.

What you will own

• Reconcile eleven trial populations across comparator requirement, enrolment, inventory, batch, expiry, pack, country and source.
• Define source tiers using authorised origin, seller chain, authenticity, licence, recall reach, lead time and usable expiry.
• Model purchase timing with enrolment confidence, overage, repack, blinding, release, import and depot replenishment clocks.
• Pilot five live sourcing decisions and expose how batch fragmentation or local packs affect protocol-ready supply.
• Trace one simulated recall from manufacturer batch through sellers, repack lots, depots, kits and affected trial countries.
• Separate operating evidence from supplier award, legal opinion, Quality release, protocol design and patient-use decisions.
• Deliver the accepted sourcing book, case library, controlled rules, owner training and funded 120-day backlog.

Candidate qualifications

• Designed global comparator sourcing for complex oncology, rare-disease or similarly constrained clinical trials.
• Has rejected apparently available medicine because source pedigree, batch, expiry, pack or import evidence was inadequate.
• Understands enrolment, overage, authorised trade, authenticity, repack, blinding, depot and recall controls operationally.
• Can build source tiers without representing a broker or assuming Quality, Regulatory, procurement or clinical authority.
• Has recovered comparator continuity after enrolment change, shortage, batch fragmentation or country restriction.
• Delivered sourcing controls that sponsor and trial-supply teams sustained across multiple protocols and jurisdictions.

Non-negotiables

• Can complete eight supplier, pack-site, depot or country reviews and five live decisions within twelve weeks.
• Will remain independent of comparator brokers, wholesalers, manufacturers, depots, packagers and trading platforms.
• Accepts Quality, Regulatory, procurement, protocol, import, site and patient-use authority boundaries.
• Brings direct global comparator sourcing; commercial pharmaceutical procurement alone is insufficient.

1. 49 words maximum. Describe comparator stock you rejected after batch, expiry, pack or seller-chain evidence failed.
2. 49 words maximum. How would you stress a purchase against a sudden 30% enrolment increase and decrease?
3. 49 words maximum. Which pedigree event must follow a manufacturer batch into blinded trial kits?