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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director, Clinical Delivery Program Lead


Reference:SCA013518 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor

Associate Director, Clinical Delivery 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 Delivery Program Lead to join their team on a permanent basis. AsAssociate Director Clinical Delivery 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:
  • Bachelor’s 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 +353879500821 or [email protected]