Associate Director/ Director

2 months ago


Stevenage, United Kingdom GSK Full time

**Site Name**: UK - Hertfordshire - Stevenage

**Posted Date**: Jan 5 2023

**Associate Director / Director**:
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:
Our approach to R&D

Clinical Pharmacology Experimental Medicine (CPEM) serves as a translational bridge between GSK research units and late clinical development. We leverage expertise in human disease, clinical pharmacology, biomarkers, imaging, and experimental medicine to define the optimal destination for cutting edge science to impact patient lives.

Discovery Medicine comprises physicians and clinical scientists within CPEM and the Research organisation, which is the organisation in GSK responsible for early-stage pharmaceutical R&D. The Discovery medicine group contributes deep scientific expertise in translational medicine and early clinical development and is responsible for the rigorous assessment of clinical tractability and therapeutic potential of new targets. In addition, the group is accountable for strategic translational planning and the design of early clinical studies, with an emphasis on using early development to de-risk investment into Phase 2 clinical proof of concept studies.

**Key responsibilities**:
**For Associate Director level**:
Responsibilities of the Associate Director Discovery Medicine include (but are not limited to):

- Responsible for ensuring that the data package required to support a Phase I study, including translational biology and enabling work (e.g. challenge models, method development) are complete. Interacts closely with a broad matrix team of projects representatives and potentially, external collaborators to enable this.
- Accountable for designing and delivering clinical study proposals and protocols for early-stage clinical studies and for presenting studies at Protocol Review Board (PRB).
- Accountable for presenting the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct.
- Accountable for providing scientific input into clinical study reports and publication/presentation of results.
- Accountable for providing clinical input to regulatory briefing documents and for addressing clinical questions from regulatory authorities/ethics committees
- Prepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences
- Contributes to the design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development.
- Contributes to presentations and supporting documentation for Research Review Board/Research Investment Board

**Additional Responsibilities for Director level**:
As a Discover Medicine Director, you will be expected to provide strategic clinical input to the overall development of an asset and to have the necessary experience to take on the role of Discovery Medicine Lead (DML) for one or more assets or indications. You will be responsible for the design and delivery of the early Clinical Development Plan (CDP), working closely with the Early Development Leader (EDL), project team and study teams to deliver data that allows a robust decision to be made on the full development of the medicine. The Director Discovery Medicine may also provide clinical support/leadership for mechanistic studies for marketed compounds or those already in late-stage development. You will be accountable for regulatory reporting requirements at the study and project level for the assets you are working on, including clinical interpretation of data.

**Responsibilities of the Director Discovery Medicine include (but are not limited to) several key areas**:

- Works closely with research members and external collaborators to define the best clinical indication for a target and integrates inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Early Medicine Profile.
- Accountable for design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development.
- Lead the Clinical Matrix Team (CMT) (or equivalent cross-functional clinical team


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