Associate Director, Clinical Trial Program Lead
1 month ago
Associate Director, Clinical Trial Program Lead Our client, a global pharma company, are continuing to grow their Clinical Development and Operations team and are currently recruiting for an Associate Director Clinical Trial Program Lead to join their team on a permanent basis. As Associate Director Clinical Trial Program Lead you will be responsible for exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. Responsibilities: Lead the development of the clinical asset strategy for phase 1 leveraging quality decision making principles Understand assigned therapeutic area including trial designs, risks and execution challenges and best practices Provide consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications and manuscripts Stay up-to-date, be informed & familiar with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices Maintains knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions e.g. FHD requirements, detail of operations to deliver critical path studies and submissions Lead the implementation and integration of clinical project management processes and tools Work with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverables Develop and maintain up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team Partner with the financial organisation, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process Proactively identify and communicate clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates and leadership Be accountable and responsible for oversight of clinical trial operations and delivery of clinical project milestones on time, on budget Create and manage implementation timeline and clinical trial activities Involved in selection process and management of vendors, providing day to day oversight for operational deliverables with external network of vendors to ensure on time and on budget clinical project deliverables Be the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward Partner with regulatory and medical to ensure safety management and monitoring processes are implemented Requirements: Bachelors degree in a science related field 3-years experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred) Strong knowledge of ICH GCP Early Phase (Phase 1) experience preferred Advanced scientific degree Strong leadership and networking skills Vendor management and contracting experience Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates) Ability to influence and oversee TPOs to enable delivery of trial level deliverables Demonstrated knowledge and experience with project management tools and processes Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships Excellent oral and written communication skills; able to communicate clearly and with team members and leadership For more information contact Sinéad Cullen on or Skills: Clinical Project Manager Clinical Trials Clinical Trials Manager
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Associate Director, Clinical Trial Program Lead
6 months ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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