Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 18 2021 Discovery Medicine is made up of the physicians and clinical scientists within the Research organisation, which is the organisation in GSK responsible for non-oncology, early-stage pharmaceutical R&D. The group contributes deep scientific expertise in translational medicine and early clinical development as well as broad medical expertise from board certified physicians across multiple therapeutic areas. The Discovery Medicine group is responsible for the rigorous assessment of clinical tractability and therapeutic potential of new targets. In addition, the group is accountable for strategic translational plan 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. Position Summary The Director Discovery Medicine will be 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. You will have a thorough understanding of the asset(s) you are working on, including their biology, and of relevant disease indications. You will be accountable for, among other things, the provision of medical 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. Following candidate selection, you will be responsible for 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 will also provide clinical support/leadership for mechanistic studies of marketed compounds or those already in late stage development. You will be accountable for medical governance and regulatory reporting at the study and project level for the assets you are working on, including clinical interpretation of data (clinical and non-clinical) related to patient safety and clinical efficacy. 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: The responsibilities of the Director Discovery Medicine include (but are not limited to) several key areas: Strategy and Matrix leadership Works closely with research members 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, Target Validation plans, and Candidate Selection 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 Medical governance and Study Safety 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.) Accountable for providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety 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 and GSK Pharmacovigilance, as appropriate Study design, protocol development, execution and reporting Regulatory Accountable for clinical input to 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 Other Interactions with Medicines Development Leader and Project Physician Leader in the Development organisation for smooth transition of programmes progressing out of the Research Organisation 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 projects in Discovery Medicine, and be independently accountable 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 Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: - Primary medical qualification, ( board certified or board eligible is a requirement) plus PhD (or equivalent) and a clinical specialty qualification (e.g., fellowship or equivalent) - Industry experience in translational medicine and early phase drug development. - Experience of setting and executing scientific strategy, whilst being mindful of overall company goals. - Understanding and knowledge of early drug development and genetics. - 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 experts. Preferred Qualifications: If you have the following characteristics, it would be a plus: Industry experience in early translation medicine Immunology experience or other TA experience, CV/ ID /dermatology Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. 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