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    Senior/ Director - Clinical Research Physician (Development)

    Lilly
    5+ years
    Not Disclosed
    Bangalore
    10 Aug. 21, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 Description: Development Clinical Research Physician (CRP)

    About Lilly

    At Lilly, we unite caring with discovery to enhance lives globally. As a leading healthcare company headquartered in Indianapolis, Indiana, our mission is to discover and deliver life-changing medicines, advance disease understanding, and support our communities through philanthropy and volunteerism. We strive for excellence in our work and prioritize putting people first. We seek individuals dedicated to improving lives worldwide.

    Role Overview

    The Development Clinical Research Physician (CRP) is primarily responsible for late-phase and marketed compounds. This role involves collaborating with various teams to develop clinical strategies and plans, support clinical trials, and contribute to regulatory and business activities.

    Key Responsibilities

    1. Clinical Planning

      • Collaborate with geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology to develop and maintain product lifecycle plans, clinical strategies, and study protocol designs.
      • Align clinical strategies with global objectives and keep updated on relevant pre-clinical and clinical data.

    2. Clinical Research/Trial Execution and Support

      • Plan and review scientific content of clinical documents (e.g., protocols, consent forms, study reports).
      • Oversee and input into Investigator’s Brochure (IB) and other clinical documents.
      • Collaborate on trial design, patient recruitment, and risk management.
      • Ensure compliance with Good Clinical Practices (GCP) and local regulations.
      • Monitor patient safety and manage adverse event tracking and follow-ups.

    3. Scientific Data Dissemination/Exchange

      • Ensure compliance with local laws, global policies, and data dissemination guidelines.
      • Address scientific information needs of healthcare professionals and support scientific meetings and publications.
      • Establish and maintain relationships with external experts and professional societies.

    4. Regulatory Support Activities

      • Participate in label development, regulatory report preparation, and risk management planning.
      • Provide medical expertise for regulatory submissions and advisory committees.

    5. Business/Customer Support

      • Develop medical strategies for brand commercialization and support customer inquiries with timely data analyses.
      • Collaborate with marketing and business teams to support brand and patient engagement.

    6. Scientific/Technical Expertise and Continued Development

      • Stay updated on medical literature, competitive products, and clinical practice trends.
      • Provide scientific training and act as a consultant for the clinical study team.

    7. General Responsibilities

      • Support business unit development budget and participate in recruitment and diversity efforts.
      • Engage in professional development, coaching, and team collaborations.

    Qualifications

    • Medical Doctor or Doctor of Osteopathy, board eligible or certified in relevant specialty/subspecialty.
    • Demonstrated knowledge of the drug development process.
    • Fluent in English with strong communication, interpersonal, organizational, and negotiation skills.
    • Ability to influence and collaborate cross-functionally.
    • Willingness to travel domestically and internationally as needed.

    Lilly is committed to providing equal employment opportunities and ensuring that individuals with disabilities can participate in the workforce. For accommodations during the application process, please contact Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com.

    Lilly 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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