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    Associate Director - Clinical Research Lead

    Eli Lily
    8-10 years
    Not Disclosed
    Gurgaon
    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 Research Lead
    Location: Gurgaon, Haryana, India
    Category: Research & Development
    Job Type: Full-Time Regular
    Job ID: R-77165

    About Lilly:

    At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, we are dedicated to discovering and delivering life-changing medicines, improving the understanding and management of disease, and contributing to our communities. We strive to make life better, and we’re looking for people who share this passion.

    Position Overview:

    The Associate Director - Clinical Research Lead (CRL) is responsible for overseeing and managing clinical sites involved in Lilly’s clinical trials. This includes ensuring site identification, qualification, enrollment, and timely database locks, as well as maintaining inspection readiness throughout the trial. The CRL ensures global program delivery by driving operational excellence and fostering strong, productive relationships with clinical trial sites. The CRL is accountable for comprehensive site management, leveraging tools for informed decision-making, and providing high-quality interactions with global clinical trial sites to ensure an unparalleled customer experience.

    Key Responsibilities:

    Clinical Investigator Management:

    • Site & Investigator Engagement: Oversee activities at clinical trial sites and work with investigators to ensure smooth site initiation, enrollment, and closeout.
    • Site Management: Ensure timely site recruitment, enrollment, and database locks; address performance issues and mitigate risks.
    • Trial Acceleration: Identify and implement strategies to accelerate trial enrollment and ensure quality data collection.
    • Strategic Partnerships: Develop and maintain strategic relationships with key clinical institutions and sites to optimize clinical trial delivery across therapeutic areas.

    Clinical Trial Management:

    • Risk & Delivery Plans: Develop and implement risk management plans to ensure timely clinical trial enrollment and database lock.
    • Inspection Readiness: Ensure that sites and countries are always prepared for inspections.
    • Metrics Utilization: Use metrics to guide decision-making and optimize site/country/regional trial performance.
    • Barriers Removal: Collaborate with internal and external teams to remove obstacles in trial execution.
    • Feasibility & Allocation: Understand local treatment paradigms and allocate trials to the most suitable sites to meet strategic needs.

    Business Management & Engagement:

    • Stakeholder Relationships: Build strong professional relationships with clinical investigators to enhance research opportunities and improve the clinical trial experience.
    • Cross-functional Collaboration: Work with cross-functional teams to ensure alignment in portfolio priorities and trial delivery.
    • Communication Bridge: Act as the main point of communication between sites, third-party vendors, and Lilly, ensuring smooth and effective collaboration.

    Leadership & Influence:

    • Strategic Agility: Demonstrate strategic agility and business acumen to navigate complex situations.
    • Leadership Behaviors: Exhibit leadership skills that influence teams, overcome challenges, and drive results even in uncertain environments.

    Minimum Qualifications:

    • Education: Bachelor's degree or equivalent (preferably in a scientific or health-related field).
    • Experience: 8–10 years of experience in the pharmaceutical industry or clinical research, with strong knowledge of Good Clinical Practice (GCP).
    • Skills:
      • Expertise in clinical research and therapeutic areas.
      • Strong self-management and organizational abilities, with the ability to prioritize and adapt.
      • Leadership and strategic thinking, including the ability to influence others and navigate challenges.
      • Excellent communication and interpersonal skills.
      • Fluent in English (additional language proficiency is a plus).
      • Strong decision-making ability and problem-solving skills.
      • Ability to work effectively with cross-functional teams.

    Preferred Qualifications:

    • Therapeutic Expertise: In-depth knowledge of therapeutic areas relevant to the clinical trials.
    • Regulatory Knowledge: Strong understanding of country-specific regulatory guidelines and requirements.
    • Customer-Centric Focus: Demonstrated ability to improve customer experience throughout the clinical trial process.
    • Project Management: Experience managing large-scale projects with attention to detail and deadlines.
    • Travel Requirements: Ability to travel (50-75%) as required.

    Additional Information:

    At Lilly, we are committed to providing equal opportunities for all individuals, including those with disabilities. If you require accommodations during the application process, please complete the accommodation request form on our careers website.

    Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.

    #WeAreLilly

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