Название центра: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence
Опубликовано: Mar 30 2021
Discovery Medicine comprises physicians and clinical scientists within the Research organisation. The group has deep scientific expertise in translational medicine and early clinical development combined with a breadth of medical expertise from board certified physicians across multiple therapeutic areas..
We are seeking a highly motivated physician 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; organisation 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.;
The Director Discovery Medicine is recognised internally and external to GSK as a leader in Drug Discovery, Development and Translational Medicine and/or as an expert in his or her disease/therapeutic area.
The Discovery Medicine group is responsible for rigorous assessment of clinical tractability and therapeutic potential to inform the most appropriate development strategy for new targets. In addition, the group is accountable for strategic translational plan and the design of early clinical studies to provide confidence to invest in Phase 2 clinical proof of concept studies.
Clinical insight into projects starting at the target identification stage is needed to give proper direction to early discovery.You will have a thorough understanding of the asset(s) you are working on, the biological mechanism(s) of action and relevant disease indications. Accountabilities will include provision of medical and scientific input into the design of one or more clinical studies within Clinical Pharmacology and Experimental Medicine (CPEM) and clinical leadership to the Research Units relating to specific diseases, target discovery and validation as well as development feasibility and potential strategies for early clinical development of compounds prior to candidate selection. You will be responsible for design and delivery of the early Clinical Development Plan (CDP), working with the Early Development Lead (EDL), project team and study teams, to deliver data that will support progression to full development of the medicine.
The Director Discovery Medicine will also provide clinical support/leadership for proof of mechanism studies (POM) for compounds in Development. You will be accountable for medical governance and regulatory reporting at the project level (and in support of the Clinical team) through clinical interpretation of data (clinical and non-clinical) that can impact patient safety and clinical efficacy.
Your ability to matrix cooperatively with the broader GSK organisation, including the Discovery Medicine group, Biology, Value Evidence and Outcomes and Commercial, as well as external collaborators, is required for successful project prosecution and determining the true ability of an asset to address unmet medical need and benefit patients.
Responsibilities of the Director Discovery Medicine include several key areas including but not limited to:
Strategy and Matrix leadership
- 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
- Accountable for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy (i.e. manufacturing, formulation, etc.)
- Accountability for providing clinical input into presentations, supporting documentation for and participation in the Research Review Board/Research Investment Board
- Accountable for escalation of clinical safety incidents to the Discovery Medicine head
- Study design, protocol development, execution and reporting
- Accountable for providing oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Physician, providing input into aspects of study design that relate to subject safety
- Accountable for clinical and risk/benefit sections of regulatory documentation to support the desired indication (e.g., IB, IMPD)
- Responsible for addressing clinical questions at meetings with regulatory authorities/ethics committees
- 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
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
- medical governance initiatives in R&D; (e.g. safety panel or governance board)
- discovery/development policy, processes or guidelines affecting the pharmaceutical industry
- training networks in/outside of GSK
- 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
Experience and Qualifications
- DO ,or MD +/- PhD (preferable) with significant clinical knowledge in Infectious Disease, as evidenced by fellowship training or prior industry experience. Experience in the treatment of Hepatitis B, respiratory viruses and/or bacterial infections would be advantageous
- In-depth experience in lab-based research or translational medicine. and Prior experience in early drug development (Research & Development) would be a plus
- Experience of setting and executing scientific strategy , whilst being mindful of overall company goals
- Track record in taking assets from lead optimisation to candidate selection
- Understanding and knowledge of early development , e.g. DMPK, biomarkers, etc.
- Experience in working with relevant regulatory bodies and professionals in early stage discovery and development
- Excellent presentation , influencing and media skills for both internal and external audiences.
- Ability to lead and contribute to a global cross-functional team of senior leaders
- 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.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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