Oncology Global Clinical Development Director (Indication Lead)

GlaxoSmithKline ,
Stevenage, Hertfordshire
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Job Description

GSK is expanding its oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting portfolio and are looking for Clinical Operations Leads who have a wide breadth of oncology and clinical development experience. It's a wonderful time to join our team because we have many opportunities to lead global studies and programs in Phases 1-3 in the areas of immuno-oncology, cell/gene therapy, epigenetics and synthetic lethality. Apply to learn more! Role Description: Accountable within the Oncology Global Clinical and Study Delivery (GCSD) team for alignment of the execution strategy across projects and studies within a designated indication. Responsible for strategic delivery of studies within the designated indication. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Collaboration with Clinical Operations Asset Leads (COALs) and Clinical Scientist Leads (CSLs) at the timepoint of Clinical Study Idea to contribute cross-project indication expertise. * Partnership with COALs through concept protocol generation to define the optimal study delivery strategy. * Interaction with protocol development stakeholders to incorporate indication-specific intricacies and lessons learned across studies/projects. * Creation of an Indication focused forum across COALs and Study Delivery Leads to share Indication expertise, optimize delivery strategy and drive consistent ways of working across teams. * Creation of strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development, to ensure consistent approaches to study delivery, data collection and reporting across a defined indication. * Contribution of relevant knowledge of scientific and medical literature in the defined indication area to apply to operational goals. * Contribution of strategic leadership to the GCSD Oncology Leadership Team to drive study delivery efficiency and performance. * Representation of GCSD on the Disease Area Strategy Team (indication specific) which spans all functional areas. The role may: * Have accountability for the management, performance and motivation of direct reports. * Have primary responsibility for delivery of a program of studies (or indication-specific group of studies) and be key point of contact for portfolio leaders in the Oncology Therapeutic Area (e.g. Early Development Leaders, Medicine Development Leaders, and/or Project Physician Leaders, as appropriate). Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Bachelor's degree in life sciences or related discipline * At least 10-15 years of oncology clinical operations experience * Experience in developing and writing study protocols, study procedure manuals, informed consent forms and clinical study reports * In depth knowledge of study management, global regulatory guidelines and ICH/GCP * Experience working with investigators, external experts, Contract Research Organizations and vendors * Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment * Excellent leadership skills * Excellent influencing and negotiation skills * Ability to work independently and proactively and to take on leadership roles on cross-functional study teams Why GSK? Our values and expectationsare 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. * Managing P&L and capital allocation. * *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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 emp

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