Associate Director/ Director

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. We are seeking a highly motivated Director or Associate Director, Discovery Medicine Scientist. As a Clinical Scientist, you will have a thorough understanding of the asset(s) you are working on including the biological mechanism(s) of action and disease indication/s. You will be accountable for the provision of clinical and scientific input into the design of early-stage clinical studies (e.g. first time in human and proof of mechanism) and for clinical leadership in target discovery and validation. Prior to candidate selection this includes evaluating clinical indications, development feasibility and potential strategies for early clinical development for targets/compounds. On programmes where you are appointed the role of Clinical Lead for a particular study or studies, you will have single point accountability for the scientific design and interpretation of the study results. To succeed in the role, the successful candidate will need to work closely with a broad matrix team of project representatives and in some cases, external collaborators. 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) Accountable for engaging external academic and clinical experts to enhance quality and delivery of discovery medicine studies Accountability for providing clinical input into presentations, supporting documentation for and participation in the Research Review Board/Research Investment Board Accountable for clinical and risk/benefit sections of regulatory documentation to support the desired indication (e.g., IB, IMPD) Accountable for regulatory reporting requirements including Development Safety Update Reports (DSUR’s) and IB updates Transition to Development organisation- Interactions with Medicine Development Leader and Clinical Development Leader for smooth transition of programs Patient perspective – accountable for incorporating patient perspective in the design and conduct of DM studies Leadership You will be highly experienced in drug development or translational medicine. You will be expected to work across multiple Discovery Medicine projects, demonstrating independent accountability for your own projects. You will set long term scientific strategy and be capable of executing this strategy based on your own expertise and that gained from your network. You will play a leadership role in business development activities representing Discovery Medicine mentoring and coaching other members of Discovery Medicine applying extensive knowledge of clinical development to more than one research unit/disease area building an external network with academia/pharma, bringing expertise back to GSK anticipating, communicating and acting on trends/events outside GSK that affect our business direction utilising command of the drug discovery and development process to influence a culture of continuous improvement Closing Date for Applications: 19/01/2023 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: MSc or PhD (preferred) with significant clinical knowledge in immunologic diseases and/or broad therapeutic expertise. Track record (at least 5 years) in translational medicine and early-phase drug development / clinical trials, with industrial experience preferred. Understanding or knowledge of early clinical development (e.g. biomarkers, drug metabolism) Excellent presentation, influencing and media skills for both internal and external audiences. Additionally for Director Experience of setting and executing scientific strategy, whilst being mindful of overall company goals Experience in working with relevant regulatory bodies and professionals in early-stage discovery and development Ability to lead and contribute to a global cross-functional team of experts Core Competencies Leadership capability – demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities. Strategic Thinking – maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems. Business Acumen – Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D. Project Management – Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics. Why GSK? Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more: Annual Report 2021 GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don’t hesitate to contact us if you’d like to discuss any reasonable adjustments to our process which might help you demonstrate your strengths and capabilities. For UK Intern roles (including Industrial Placements) you can either call us on 01582 692870, or send an email [email protected] For UK Apprentice and Graduate Programme roles (including Future Leaders Programme) you can either call us on 0203 862 2277, or send an email [email protected] As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.