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    Associate Director - Clinical Research Lead

    Lilly
    8-10 years
    Not Disclosed
    Gurgaon India
    10 Feb. 11, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Primary Responsibilities:

    1. Clinical Investigator Management:

      • Lead activities required at clinical trial sites, including site identification, qualification, enrollment planning, execution, database lock, and closeout.
      • Ensure timely delivery of site management activities, including enrollment readiness, recruitment, and performance management, as well as issue mitigation.
      • Identify opportunities to accelerate trial enrollment while driving a superior clinical trial and customer experience.
      • Apply scientific and therapeutic expertise to ensure timely trial enrollment and quality data.
      • Build strategic relationships with sites and institutions to optimize trial program delivery across therapeutic areas.

    2. Clinical Trial Management:

      • Develop and implement site risk plans to ensure on-time trial enrollment and database locks.
      • Ensure site and country-level inspection readiness at all times.
      • Leverage metrics to support decision-making at the site, country, and regional levels.
      • Collaborate with internal and external teams to resolve execution barriers at sites or country levels.
      • Understand local treatment paradigms to support trial feasibility and strategic allocation.
      • Oversee vendors conducting site monitoring activities at the site and country level.

    3. Business Management and Engagement:

      • Develop and maintain professional relationships with clinical investigators to expand and maintain clinical research partnerships.
      • Align priorities across functions and deliver portfolio objectives.
      • Target and prospect sites in alignment with portfolio strategy.
      • Maintain therapeutic and technical expertise for scientific discussions with investigators and site personnel.
      • Serve as a communication bridge between sites, vendors, and Lilly.
      • Influence internal and external factors to improve clinical research delivery.

    Minimum Qualification Requirements:

    • Education: Bachelor's degree or equivalent.
    • Experience:
      • 8-10 years of experience in the pharmaceutical industry and/or clinical research, with strong knowledge of Good Clinical Practice (GCP).
      • Therapeutic expertise and knowledge of the clinical research landscape.
      • Strong self-management and organizational skills with the ability to prioritize workloads and adjust accordingly.
      • Demonstrated strategic agility and business acumen.
      • Leadership experience with the ability to lead through challenges, remove barriers, and influence without authority.

    Other Information/Additional Preferences:

    • Preferred Qualifications:
      • Bachelor's degree in a scientific or health-related field.
      • Strong communication (verbal and written) and language skills.
      • Strong organizational and planning skills.
      • Ability to enhance the customer experience and develop creative solutions.
      • Fluent in English and required languages for conducting business.
      • Knowledge of country regulatory guidelines and requirements.
      • Strong interpersonal and teamwork skills.
      • Ability to make decisions and apply creative solutions.
    • Travel: Required (50-75%)

    Equal Opportunity Statement:

    Lilly is committed to ensuring equal opportunities for individuals with disabilities and actively encourages their participation in the workforce. If you require accommodation to submit your resume for a position at Lilly, please complete the accommodation request form.

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

    #WeAreLilly

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