Job Description
Associate Director, Clinical Trial Program LeadAssociate Director, Clinical Trial Program LeadOur client, a global pharma company, is continuing to grow their Clinical Development and Operations team and is 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 principlesUnderstand assigned therapeutic area including trial designs, risks and execution challenges and best practicesProvide 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 manuscriptsStay up-to-date with current knowledge of relevant disease states/targets, competitors, and industry trendsMaintain knowledge of operational requirements to effectively plan exploratory and biopharmaceutics clinical development studies and submissionsLead the implementation and integration of clinical project management processes and toolsWork with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverablesDevelop and maintain up-to-date clinical plan timelines and process maps, ensuring communication of progress to the broader molecule teamPartner with the financial organization and cross-functional partners to manage the overall clinical budgetProactively identify and communicate clinical risk assessment and mitigation plansBe accountable for oversight of clinical trial operations and delivery of clinical project milestones on time and on budgetCreate and manage implementation timeline and clinical trial activitiesInvolved in selection process and management of vendors, providing oversight for operational deliverablesBe the central point of contact for the global clinical team to resolve clinical implementation issuesPartner with regulatory and medical to ensure safety management and monitoring processes are implementedRequirements:Bachelor’s degree in a science-related field3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies (5+ years preferred)Strong knowledge of ICH GCPEarly Phase (Phase 1) experience preferredAdvanced scientific degreeStrong leadership and networking skillsVendor management and contracting experienceDemonstrated high-level computer skills (e.g., word processing, spreadsheets, presentations)Ability to influence and oversee TPOs to enable delivery of trial level deliverablesDemonstrated knowledge and experience with project management tools and processesExcellent oral and written communication skills #J-18808-Ljbffr