Associate Director Clinical Trial Program Lead Job In Cork

Job Description

Lead a team in the development of clinical asset strategies for phase 1, leveraging quality decision-making principles, and provide technical leadership and operational oversight of clinical research trials.

**Responsibilities:** • Develop clinical asset strategies for phase 1, incorporating quality decision-making principles • Provide consultation to project teams on clinical and regulatory documents, including study protocols, Investigator Brochures, risk profiles, and annual reports • Stay up-to-date with current knowledge of relevant disease states, competitors, and industry trends • Maintain knowledge of operational requirements to effectively plan exploratory and biopharmaceutics clinical development studies and submissions • Lead the implementation and integration of clinical project management processes and tools • Work with third-party organizations to execute the defined clinical strategy, overseeing key trial deliverables • Develop and maintain up-to-date clinical plan timelines and process maps, ensuring communication of progress to the broader molecule team • Partner with financial and cross-functional partners to manage the overall clinical budget • Proactively identify and communicate clinical risk assessment and mitigation plans • Be accountable for oversight of clinical trial operations and delivery of clinical project milestones on time and on budget **Requirements:** • Bachelor's degree in a science-related field • 3 years' experience in the pharmaceutical industry with direct experience of managing clinical studies (5+ years 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 computer skills (e.g., word processing, spreadsheets, presentations) • Ability to influence and oversee third-party organizations to enable delivery of trial-level deliverables • Demonstrated knowledge and experience with project management tools and processes • Excellent oral and written communication skills