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    Associate Director - Clinical Development

    Eli Lily
    5+ years
    Not Disclosed
    Cork
    10 Jan. 29, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Associate Director - Clinical Development
    Location: Cork, Cork, Ireland
    Category: Research & Development
    Job Type: Full-Time, Regular
    Job ID: R-78275

    About Eli Lilly

    At Lilly, we are committed to discovering and delivering life-changing medicines that help improve the lives of people worldwide. As a global healthcare leader, we have a diverse team of employees from all over the world, including 2,000+ colleagues in Cork, Ireland. At Lilly Cork, we foster a work environment that prioritizes innovation, collaboration, and diversity. We offer a premium workspace, flexible working options, and a comprehensive benefits package that includes healthcare, pension, wellness programs, and educational assistance. Our commitment to diversity, equity, and inclusion ensures a workplace where everyone is valued and can thrive.

    Job Summary

    The Associate Director - Clinical Development will provide leadership and direction to consultants, associates, and assistants supporting clinical trials within the Clinical Development (CD) organization. This role ensures high team performance, aligning trial-level planning and execution with broader asset strategy. You will manage clinical operational oversight for regional/global study deliverables, including trial enrollment targets, while ensuring compliance with regulations and clear implementation of processes.

    Key Responsibilities

    1. Business Planning and Strategy:

    • Partner with functional, cross-functional, and team leadership to provide operational input on clinical plans, resource requirements, and feasibility.
    • Provide strategic leadership to Clinical Trial Project Managers (CTPMs) to ensure successful implementation of the regional/global enrollment strategy.
    • Collaborate with key stakeholders, such as Medical Sourcing, Procurement, and Compound Team Management, to support sourcing decisions.
    • Maintain accuracy and up-to-date information in planning databases.

    2. Resource Management:

    • Align resources based on team priorities and regional participation in clinical trials.
    • Manage workloads for study management personnel, balancing global and regional needs and individual expertise.
    • Lead discussions on team priorities and address unplanned demands.
    • Recruit, retain, and develop top talent to foster a high-performing team culture.

    3. Trial Management Expertise:

    • Facilitate problem-solving, shared learning, and decision-making across clinical functions.
    • Participate in risk assessments at the clinical plan level and ensure development of cross-functional risk management plans.
    • Ensure study teams are inspection-ready and provide coaching to Clinical Development Team Leaders (CDTLs) on compliance and issue resolution.

    4. Training and Compliance:

    • Collaborate with the training group to ensure staff training is up-to-date and compliant with GCPs, global SOPs, and clinical best practices.
    • Provide coaching to team members and monitor training compliance to ensure all required courses are completed on time.
    • Foster quality in clinical research activities through adherence to GCPs and SOPs.

    5. Process Improvement:

    • Lead and contribute to the development of new processes and process improvements to enhance productivity and quality.
    • Encourage staff to utilize metrics to assess clinical program status and identify opportunities for improvement.
    • Assess the impact of process changes and work towards achieving project team goals.

    6. Communication and Stakeholder Engagement:

    • Collaborate with cross-functional leadership to resolve clinical trial operational issues.
    • Lead high-level discussions with vendors and other stakeholders as needed.

    7. Performance Management:

    • Manage the Performance Management process, including setting objectives, reviewing progress, providing feedback, and documenting performance.
    • Participate in talent assessment and succession planning for direct reports.

    Basic Qualifications

    • Education: Bachelor’s degree in a scientific or health-related field (advanced degree preferred).
    • Experience:
      • Minimum of 5 years of clinical trial experience or relevant experience in a scientific or health-related field.
      • At least 5 years of clinical research experience with a strong working knowledge of the clinical research process.

    Additional Skills and Preferences

    • Demonstrated expertise in clinical trial development, with an understanding of the drug development process and inter-dependencies across functional groups.
    • Strong communication and leadership skills with the ability to influence and lead across clinical functions.
    • Proven ability to coach others and manage teams virtually, across borders and cultures.
    • Experience in managing global clinical trials and business plans.
    • Strong organizational and self-management skills, with the ability to balance multiple priorities and meet deadlines.
    • Experience with the management of resources and expertise in clinical trial strategy and execution.

    Additional Information

    • Travel: Some travel may be required.
    • Diversity Commitment: Eli Lilly is committed to providing equal opportunities for individuals with disabilities. If you require accommodations to participate in the application process, please complete the accommodation request form available on our careers website.

    #WeAreLilly

    Eli Lilly is an Equal Employment Opportunity/Affirmative Action employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

     

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