Clinical Development Medical Director

1 month ago

East Hanover, United States Novartis Farmac??utica Full time

Onsite Location: East Hanover, New Jersey Hybrid About the role:

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. As Sr CDMD, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. You will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.

In Clinical Development Oncology, our aim is to design innovative, patient–friendly clinical development plans to rapidly bring outstanding treatments to patients, caregivers and healthcare systems. We are striving to develop treatments for Lung, Breast & Prostate Cancers, MDS & AML, CML and sickle–cell disease, and are pushing the boundaries of innovation with CAR–T and Radioligand therapies. 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 overall program safety reporting in collaboration with Patient Safety colleagues.
  • 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, and contributing to/driving development of disease clinical standards for new disease areas.
  • 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 in addition to advanced knowledge and clinical training in 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–4 required.
    • 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 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. Ready to create a brighter future together? 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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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