Sr. Clinical Development Director - Infectious Diseases
Site Name: UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jul 9 2021 Here at GSK, we are strengthening our pipeline through a focus on science related to the immune system, the use of human genetics and advanced technologies. Our early stage research is not constrained by therapy areas with teams actively encouraged to follow the science. As projects progress potential new medicines are aligned to the therapy area where data shows we can have the greatest impact to the largest number of patients' lives. Our current therapy areas of focus includes emerging indications and assets in Infectious Diseases (ID). We're seeking a Sr. Clinical Development Director - Infectious Diseases to lead pivotal studies for the antibacterial portfolio with flexibility to adapt to other projects in the ID portfolio as required. You'll be responsible for creating and executing the clinical development strategy for emerging pipeline of antibacterials and other ID assets as needed. Working with colleagues in Specialty Medicines with Clinical Sciences, which includes Neurosciences, Infectious Disease, Rare Disease, Cardiovascular, Metabolic and Renal disease. This role will provide you the opportunity to work in a culture that incentivises courageous and smart risk-taking to help deliver the next generation of transformational medicines. Job Purpose and Key Responsibilities: Providing integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development Strategic Leadership: Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the IEP and CDP Generating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Establishing expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line management Scientific Leadership, Direction and Strategy: Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compounds Serving as clinical matrix team leader and a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development Leading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need Integrating inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile. Accountable for risk/benefit of the asset. Actively leads and makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit Anticipating problems and proactively seeks input from other teams' members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems Accountable for the evaluation of clinical study/program probability of technical success (PTS) Study & Program Design and Evidence Generation Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management Leads clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses Provides effective leadership support / oversight of evidence generation activities to assure patient safety and study delivery Delivers value and access insights to inform medical strategy, expand market access and to address unmet patient need Creating Innovative Scientific and Technical Solutions: Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business Why you? Basic Qualifications: PhD Extensive experience in Infectious Diseases clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication. Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication Proven ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plans Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules Demonstrated experience using new learning and digital tools to create innovation in other areas Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content Preferred Qualifications: MD Significant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance 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. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. 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