Senior Clinical Development Medical Director, Oncology

3 weeks ago

East Hanover, United States Novartis Farmac??utica Full time
Senior Clinical Development Medical Director, Oncology

Job ID: 393918BR

Aug 02, 2024

Location: East Hanover, New Jersey (Hybrid) Summary

Novartis is deeply committed to transforming the lives of people living with solid tumors, blood cancers, and serious or life–threatening blood disorders. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms, and free from disease – this is our vision for the future.

As the Senior Clinical Development Medical Director (CDMD), you will lead the strategic planning and management of the assigned clinical program from an end–to–end clinical development perspective. You will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. Your Key Responsibilities:

  • Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
  • Leading development of clinical sections of trial and program level regulatory documents.
  • Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable.
  • Support the Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT).
  • Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP), and Clinical Trial Protocol (CTP) reviews.
  • As a medical expert, supporting the GPCH or CDH in interactions with external and internal stakeholders and decision boards. Minimum Requirements:
    • MD or equivalent medical degree is required, with advanced knowledge and clinical training in the medical/scientific area; Clinical practice experience: 4 years (including residency) preferred.
    • Minimum of 7 years of experience in clinical research or drug development.
    • Experience in an academic or industry environment spanning clinical activities in Phases I–IV required.
    • 2 years of contribution to and accomplishment in all aspects of conducting clinical trials in a global/matrix environment in the pharmaceutical industry required.
    • Working knowledge of Oncology is required, with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trials.
    • Demonstrated ability to establish effective scientific partnerships with key stakeholders.
    • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
    • Previous global people management experience is preferred, though this may include management in a matrix environment. Why Novartis:

      Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Commitment to Diversity & Inclusion:

      The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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