Senior Director, Cmc Digital

**Site Name**: UK - Hertfordshire - Stevenage, Rixensart, USA - Pennsylvania - Upper Providence

**Posted Date**: Jul 18 2023

GSK R&D and Digital and Tech’s collective goal is to deliver business impact, including the acceleration the discovery and development of medicines and vaccines to patients. The R&D Digital and Tech remit has expanded over the past 2 years, and to position GSK for the future, there is an R&D driven need to have a specific focus on the latter stages of the vaccine and medicine development cycle known as CMC (Chemistry, Manufacture and Control) to power how GSK moves from two to four assets through the mid and late stage pipeline every year. As a result, R&D Digital and Tech, need to have a significantly expanded leadership role to focus specifically on CMC across all vaccine and medicine modalities that delivers seamless data collection, data collation and presentation to meet the R&D ambition for Digital, Data and Analytics (DDA) and the transfer of information to support the commercial manufacture during New Product Introduction (NPI). The change will strengthen R&D Digital & Tech; providing more strategic impact, focus, accountability, and improved decision making in using DDA to strengthen the pipeline.

The Head, CMC Digital & Tech is responsible for delivering a Digital & Tech investment over ~£40M/annum and oversees the delivery executed by a workforce of ~270 GSK and 3rd party colleagues. Technology is business critical for R&D from both a compliance and business continuity perspective, an enabler to accelerate medicines and vaccines development for patients, as well as a driver of efficient operations within R&D CMC functions.

The Head, CMC Digital & Tech is a trusted thought leader on Tech, Digital, Data, and Analytics to R&D Leadership Team and is single point accountable owner for relationship and Tech performance in clinical manufacture and clinical supply of medicines and vaccines to R&D, including single point accountability for supporting Narendra Bam, head of Medicines Development & Supply (MDS) and the Technical R&D (TRD) group of Phil Dormitzer’s Vaccines R&D organisation.

The Head, CMC Digital & Tech collaborates with the other leaders in R&D Digital & Tech, GSC Tech, GSC and R&D to have an aligned and deliverable strategy that enables the progression of four assets a year through CMC and seamless tech-transfer for launch and commercial manufacturing. The Head, CMC Digital & Tech will provide delivery oversight of the GLT prioritized CMC Digital, Data & Analytics strategy, which is also a workstream of the GSC 2030 transformation strategy. At the CMC Digital Council, this leader will make decisions that impact both the R&D and GSC Digital & Tech delivery roadmaps.

The Head, CMC Digital & Tech is responsible for integrating digital and technology systems leveraged by scientists, engineers and supply chain professionals within GSK’s laboratories and pilot plants, that includes experiment capture technologies, registration, inventory, materials management, digital twins and analytics, and integrated data products which capture and make data available in foundational layers of the scientific data environment and inform portfolio decisions. The leader works to standardize technology used throughout the laboratories and pilot plants, facilitating, and embedding data standards into scientific capture, and collaborates with data scientist and computational research leadership to ensure data captured can provide value for secondary research. The leader will also work to enable DDA solutions which improve R&D productivity, including the efficiency and experience of scientists. Digital & Tech roadmaps that underpin critical business processes in medicine and vaccine CMC are also maintained to ensure GSK functional lines maintain their license to operate.

The Head, CMC Digital & Tech will drive the strategy for a new investment in data engineering capability for GSK focussed on CMC. This industry-differentiated investment will ensure that all data engineering and data pipelining requirements are built to expose data across this scientific diaspora. This role requires a digital literacy necessary to attract, recruit, retain and grow a new engineering capability at GSK and will work seamlessly with the product ecosystem that unlocks the power of CMC data, and delivers the rapid insights required by R&D objectives.

The leadership role will partner closely with Discovery, Laboratory, Development, Research Data Platform, Global Supply Chain and Global Quality Digital & Tech divisions to ensure compliance with rapidly growing regulations (e.g., IDMP) and to also unlock new value opportunities in the identification and supply of new transformational medicines and vaccines.

The role is focused on delivering technology, digital, data and analytics strategy and products to the Medicine Development and Supply, and Vaccines R&D’s TRD functions globally. Products delivered