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Director or Associate Director, Discovery Medicine Scientist, Infectious Diseases

Employer
GSK
Location
Collegeville, Pennsylvania; Collegeville, Pennsylvania
Salary
Competitive
Closing date
Oct 5, 2022
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We are seeking a highly motivated Director or Associate Director, Discovery Medicine Scientist, Infectious Diseases to work on new treatments to address the threat of infectious diseases. The Infectious Diseases Research Unit is one of four Research Units in the R&D organization at GSK and is responsible for the discovery of novel approaches and targets to treat infectious diseases that threaten our health and progressing them to clinical proof of concept studies. The Research Unit has an impactful portfolio of projects in bacterial infections, hepatitis B and viral respiratory infections (including COVID-19) along with collaborations with Vir Biotechnology and 23&Me.

Clinical Pharmacology Experimental Medicine (CPEM)serves as a translationalbridge 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 organization, which is the organization 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 :

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

For Associate Director Level:

Clinical insight into projects starting at the target identification stage is needed to give proper direction to early discovery. 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. Prior to candidate selection this includes evaluating clinical indication/s, development feasibility and potential strategies for early clinical development for targets/compounds. 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). You will be accountable for regulatory reporting at the study level for the assets you are working on, including clinical interpretation of data (clinical and non-clinical). On programs 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.
  • 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


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 at the study and project level for the assets you are working on, including clinical interpretation of data (clinical and non-clinical).

Responsibilities of the Director Discovery Medicine include 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 organization- 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 Responsibilities:

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
  • Utilizing command of the drug discovery and development process to influence a culture of continuous improvement


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD with significant clinical knowledge in Infectious Disease.
  • Experience in translational medicine and early-phase drug development / clinical trials in an industry and/or academic setting (3 years or more for Associate Director level, 5 years or more for Director level).
  • Experience working in early development (e.g. biomarkers, drug metabolism)
  • Presentation, and media skills for both internal and external audiences.


Director Level Qualifications:
  • Experience of setting and executing scientific strategy combined with 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


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience in the treatment of Hepatitis B, respiratory viruses and/or bacterial infections
  • Experience in asset development from lead optimization to candidate selection.
  • 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, organizing 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?

We're uniting science, technology and talent to make a difference in more people's lives, and revolutionizing the way we do R&D.

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.

Our pipeline currently comprises of more than 60vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we've delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

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.

#LI-GSK

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.

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