Associate Clinical Development Medical Director, Oncology
Novartis
Basel, Switzerland
vor 3 Tg.

Job Description

1 in 8! Almost one in eight women will be directly confronted with breast cancer at some time during their lives. As an Associate Clinical Development Medical Director (Assoc.

CDMD), you will join the solid tumor team at Novartis in Basel, who are working to transform the lives of all patients living with breast, lung, and head and neck cancers.

You will be responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data.

You may also be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity.

Your responsibilities will include :

  • Clinical leadership, medical and scientific strategic input, and contribution to development of trial related documents (e.
  • g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP).

    Developing materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations

  • Medical and scientific input, and contribution to clinical sections of trial and program level regulatory documents (e.
  • g., Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)

  • In collaboration with appropriate Clinical Trial Team members, ensure direct medical support of trials as needed and may act as medical monitor.
  • Conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s), manage patient safety and report on trial data to safety and clinical boards (e.

    g., Safety Management Team, GCT, GPT) and provide input into final analyses and interpretation including the development of the Clinical Study Report(s), publications and internal / external presentations

  • Under the direction of the (Sr.) GPCH or (Sr.) CDMD, contribute to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety
  • Contribute to talent and career development of Clinical Development associates through on-boarding, coaching, and / or mentoring support;
  • develop and foster Clinical Development culture; and may contribute to the performance evaluation of Clinical Trial Team members

    Minimum requirements

    What you’ll bring to the role :

  • MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical / scientific area (e.g.
  • internal medicine or sub-specialty) preferred

  • Working knowledge of Oncology is preferred, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) at program level
  • Previous experience of clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
  • 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global / matrix environment in pharmaceutical industry

  • Demonstrated ability to establish effective working relationship with key stakeholders
  • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
  • Fluent oral and written English skills
  • WHY CONSIDER NOVARTIS?

    750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

    We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

    We are Novartis. Join us and help us reimagine medicine.

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