Head of Development

Clinical Development Director - Hepatology page is loaded Clinical Development Director - Hepatology
Apply locations UK - Hertfordshire - Stevenage USA - Pennsylvania - Upper Providence time type Full time posted on Posted 3 Days Ago job requisition id 393584 Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, this Clinical Development Director opportunity could be an ideal opportunity to explore.
We are seeking a Clinical Development Director for a clinical program in Liver Disease . The Clinical Development Director will support the Clinical Development Lead (CDL) and clinical team to plan and execute a clinical program, consisting of late-stage studies in liver disease, with an opportunity to support multiple indications as part of this program’s life cycle management plans. You will work as part of a cross-functional team to deliver on a high-priority program, while also contributing to a dynamic and collaborative Clinical Research community of physicians and scientists.
Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development
Ensuring alignment with and support of project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with 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.
Enabling robust protocol design, including selection of clinical endpoints, patient populations, and participant monitoring strategy
Working with Clinical Operations to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
Medical monitoring of ongoing studies (if an MD) and interpretation and presentation of clinical data for clinical study reports and publications
Developing and maintaining relationships with program counterparts, including Commercial, Research, Regulatory, Clinical Operations, and Statistics
Interfacing and influencing a diverse range of scientific external experts (e.g., Gathering and supporting the integration of inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the Medicine Profile
Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development
Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Sciences
Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members
Experience in clinical drug development with an understanding of the hepatology disease space, the underlying biology, and potential therapeutic targets, as well as current and future potential treatment options
understanding of clinical development planning and running clinical trials from concept to publication.
Knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
Experience using new learning and digital tools to create innovation in other areas.
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.
Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance.
Demonstrated experience integrating genetic data to inform and guide clinical protocols.
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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).
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Medical Director-Oncology Clinical Development - Immuno-Oncology
locations USA - Pennsylvania - Upper Providence time type Full time posted on Posted 17 Days Ago Expressions of Interest - Oncology Clinical Development Physicians
locations USA - Pennsylvania - Upper Providence time type Full time posted on Posted 13 Days Ago We are 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.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.