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Associate Director - Clinical Project Manager (ViiV)

Posted 3 hours 55 minutes ago by Viiv Healthcare

Permanent
Full Time
Executive Jobs
London, United Kingdom
Job Description
We are a specialist pharmaceutical company 100% dedicated to developing medicines to treat and prevent HIV. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, our ambition is to end the HIV epidemic.As the pioneers in HIV innovation, we constantly look to push the boundaries of science to develop medicines that can change lives and give people more choice. Beyond our medicines, we are proud of our deep connection with the HIV community and work with partners to advance research and development, address HIV-related stigma, increase access to our medicines and provide funding and support to local community organisations to support their efforts in the HIV response.We are ViiV Healthcare. Here until HIV and AIDS are not. Role Overview The Associate Director Clinical Project Manager is responsible for developing and managing integrated clinical study plans that translate the clinical development strategy into executable, optimized delivery plans across the study lifecycle (study concept report completion).This role partners closely with Portfolio & Project Management (PPM), Clinical Study Teams (CSTs), Global Study Leads (GSLs), and functional line representatives to ensure on-time, high-quality delivery, proactively de-risk programs, enable acceleration opportunities, and provide regular analysis and recommendations to senior clinical and project leadership.The Clinical Planning environment is highly matrixed and requires extensive knowledge of clinical development across the globe and project management deliverables, as well as strong personal skills in communication, influencing, and problem-solving. In this role you will Driving and embedding early engagement with teams to influence good planning behaviours and evidence-based decision making. Partners with the PPM Project Managers, Clinical Study Teams (CSTs), and Clinical Development Leads (CDLs) to develop robust and reliable clinical study plans aligned with the Clinical Development Strategy and synchronised with the Medicines Development Plan (MDP), whilst identifying risks, offering solutions, and ensuring responsibility for translating the clinical strategy into a competitive, optimised plan with clear go/no-go decision points and a streamlined critical path. Lead effective clinical planning activities and deploy clinical project management discipline (timeline development and management (MS Project), risk assessment, contingency planning, critical path management etc) working across functional lines and all study milestones (study concept through to report completion) Develop, own and maintain detailed clinical study plans aligned with the Medicines Development Plan (MDP) and aligned to the clinical development strategy. Create a detailed clinical study plan to deliver selected studies in tools ViiV identifies which can be incorporated into the MDP. Align with PPM to ensure source systems reflect the current clinical plan assumptions to enable integrated planning across the project, and ability to track performance against baseline and current plan Establish and maintain effective working relationships to enable communication and teamwork to deliver effective strategies and actions required to identify risks and issues, mitigate and overcome study challenges Translate strategy into optimized execution plans with clear go/no go decision points and a streamlined critical path. Partner with the CSTs to define opportunities for acceleration and manage the assumptions regarding resources needed to accelerate. Be a thought partner to the PPM Project Manager on strategies that would enable acceleration. Monitor study progress versus plan; work directly with GSLs and functional leads to proactively review risks, propose mitigations and contingency options, and re-baseline when required. Provide analysis and recommendations to the ViiV Head of Clinical Sciences & Operations and the PPM Project Manager. Adjust the plan when required to support & coordinate its ultimate delivery. Support regulatory submission planning activities in conjunction with PPM and the Global Regulatory Submission Manager when required. Drive preparation of strategic scenario analyses to evaluate delivery acceleration and alternatives. Establish and maintain effective cross-functional relationships to enable clear communication, timely decisions, and collaborative problem solving. Core responsibilities include some of the following End to end clinical study planning and delivery oversight (concept reporting). Development and maintenance of MS Project timelines and integrated plans. Risk and contingency planning workshops and documentation. Performance tracking, regular status reporting, and escalation management. Support for study governance forums and decision-making checkpoints. Oversight of outsourced Clinical Project Managers Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: BSc degree in a scientific or business discipline. Seasoned Clinical Development Project Manager with a minimum of 10 years' clinical development experience with demonstrated ownership of study- and program-level planning and delivery. Proven expertise with MS Project and other detailed planning tools. Strong pro-active leadership in cross-functional matrix environments with a focus on delivery, study efficiencies, and acceleration. Excellent stakeholder management and communication skills; ability to provide clear, actionable recommendations to senior leadership. In depth understanding of clinical development process Demonstrated experience in risk identification, contingency development, and re-baselining. Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Knowledge of GSK/ViiV processes and systems. Prior experience in HIV drug development preferred. Experience working with Global Study Leads (GSLs)/Global Study Managers (GSMs), CDLs and integrated project teams. Track record of identifying and delivering study acceleration strategies. Experience supporting regulatory submission planning.ViiV Healthcare is a global specialty HIV company, the only company that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to leave no person living with HIV behind. We do this by being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We will push through every challenge until HIV/AIDS is eradicated.ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV pandemic.We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals
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