Questa posizione è in GSK
Il processo di selezione sarà interamente gestito GSK.
Questa occasione è disponibile in Upper Providence, Wavre - Belgium, Siena - Italy, Rixensart - Belgium, Ware - United Kingdom.
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Position Summary You will lead the early CMC research and development of clinical products from lead candidate optimization stage (Commit to Lead Optimisation, C2LO) through Phase 2 development, ahead of the start of the Phase 3/commercial process development. This is a matrix leadership role and you will work across multidisciplinary teams and with external partners to define development strategies, drive technical delivery and ensure regulatory readiness. The role holder will engage with the Research/ Discovery project leadership at or before C2LO milestone providing strategic CMC input and guidance, and lead CMC activities of an asset through candidate selection, Phase 1 process development, and preclinical and Phase 1supply, before transitioning asset accountability to the late-stage CMC leader in support of Phase 3 delivery.
The timing of this transition will depend on therapeutic area, modality, complexity and acceleration as needed by the business. Key Responsibilities:
- Lead the CMC strategy development and execution from early development through Phase 2 and into late-phase planning.
- Seamlessly transition project from medicine design / early discovery into Phase 1 development and manufacture, taking matrix leadership accountability to establish the CMC matrix team during candidate lead optimization.
- As core member of the Early Development team (EDT) and in partnership with Early Development Lead (EDL) define the early medicine development strategy and the early medicine commercial vision.
- As leader of the CMC matrix team (including DS, DP, analytical, manufacturing, supply chain, quality and CMC regulatory), define the integrated CMC development strategy and generate fit-for-phase development plans, risk mitigations, and technical option
📌 Director, Early Development CMC Leader (Siena)
🏢 Gsk
📍 Siena