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    Tco Physician

    Novartis
    5+ years
    Not Disclosed
    India
    10 Dec. 25, 2024
    Job Description
    Job Type: Full Time Education: MD 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: Medical Expert for Translational Clinical Oncology (TCO) Trials
    Location: Hyderabad, India
    Company: Novartis
    Division: Biomedical Research
    Functional Area: Research & Development
    Employment Type: Regular, Full-Time

    Job Summary:

    The Medical Expert for Translational Clinical Oncology (TCO) Trials provides global medical leadership for wind-down studies and co-leadership for active TCO studies. This role focuses on clinical strategy, data analysis, and the execution of TCO projects, while ensuring adherence to regulations and best practices. The position offers an opportunity to mentor junior team members and influence high-performance cross-functional collaborations.

    Major Accountabilities:

    • Scientific & Medical Expertise:

      • Provide expert scientific and medical input into assigned clinical projects in TCO, especially for oncology-related studies.
      • Contribute to the clinical strategy for the Asian region, ensuring alignment with global goals.
      • Oversee the wind-down phase of TCO projects, reviewing clinical data, and ensuring the completion of Clinical Study Reports (CSRs) and other related activities.

    • Data Analysis & Review:

      • Coordinate data analysis and interpretation for assigned TCO projects, ensuring the development of first interpretable results.
      • Contribute to the creation of clinical study reports, publications, and internal/external presentations.
      • Collaborate with teams to maintain high-quality clinical trial data and ensure effective review processes.

    • Team Leadership & Mentorship:

      • Build and maintain high-performance, cross-functional teams within TCO and with external partners.
      • Mentor and coach junior TCO team members, fostering a culture of continuous learning and professional development.

    • Compliance & Continuous Improvement:

      • Ensure all activities comply with company standards, ICH-GCP, and local regulations.
      • Advocate for continuous improvement in clinical trial quality and operational excellence.

    • Stakeholder Engagement:

      • Manage internal and external stakeholder relationships, ensuring effective communication and alignment with project goals.
      • Contribute to the training of colleagues across TCO India.

    Key Performance Indicators:

    • Successful management and execution of assigned studies, adhering to timelines, budgets, and quality standards.
    • Development of high-quality trial reporting and regulatory documents.
    • Effective risk management in the design, planning, and execution of clinical trials.
    • Achievement of department objectives and positive feedback from stakeholders.
    • Adherence to Novartis Values and Behaviors.

    Minimum Requirements:

    Education & Qualifications:

    • MD required. Board certification or prior industry experience in oncology is required.

    Work Experience:

    • >5 years of pharmaceutical or biotech industry experience.
    • Experience in oncology trials, particularly early clinical development.
    • Strong knowledge of Good Clinical Practice (GCP).
    • Proven ability in operational project management, with excellent planning, prioritization, and organizational skills.
    • Experience in clinical data analysis, risk management, and scientific contribution to clinical and preclinical projects.
    • Demonstrated strategic thinking, clear communication, and the ability to influence key stakeholders.
    • Ability to manage multiple priorities and adapt to a changing environment.

    Skills:

    • Expertise in oncology, clinical trial design, and data analysis.
    • Excellent written and verbal communication in English.
    • Strong interpersonal skills, with a track record of building relationships with internal and external stakeholders.

    Why Novartis?

    Novartis is committed to improving and extending the lives of patients through innovative science. The company fosters a collaborative environment where individuals are empowered to drive breakthroughs in healthcare. As part of the Novartis team, you'll have the opportunity to influence global projects and work with a passionate, diverse community focused on delivering life-changing therapies.

    Benefits & Rewards:

    Learn more about the benefits and rewards offered by Novartis in their Life Handbook.

    This role provides an exciting opportunity for an experienced oncology medical expert to lead TCO trials, contribute to cutting-edge research, and make a significant impact on global clinical strategies.

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