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Clinical Development Medical Director
vor 4 Monaten
90% Is the percentage of our treatments in development with the potential to be first in class or first in a specific indication
- Novartis is deeply committed to transforming the lives of people living with solid tumors. 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.
- Our mission is to reimagine medicine to extend and improve peoples lives - and our overall company strategy to achieve this is to Focus Novartis as a leading medicine company powered by data science and advanced therapy platforms such as Radioligand Therapy (RLT).
- Novartis has become the industry leader in RLT after the acquisition of Advanced Accelerator Applications (AAA) and Endocyte in 2018, together with other significant investments to advance radioligand research. Novartis Oncology is now developing a wide range of targeted RLTs, and precision Radioligand Imaging (RLI) agents, for oncology with a rich pipeline targeting multiple tumor types through a phenotypic precision medicine approach.
- Nuclear Medicine (NM) expertise is key for Novartis Oncology to expand RLT and supportive RLI agents in a sustainable manner.
- The Clinical Development Medical Director (CDMD) is responsible for leading the planning and management of the assigned RLI clinical program(s) to support the RTL trials from an end-to-end clinical development perspective. As CDMD, you will have oversight of assigned programs and drive execution of the plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
- Your responsibilities as a Nuclear Medicine expert will include:
- Providing clinical leadership and strategic medical input for all clinical results in the assigned project or section of a clinical program
- Leading development of RLI related clinical sections of trial and program level regulatory documents
- Driving execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
- Supporting (Senior) 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 Nuclear Medicine physician specialist, supporting the (Sr.) GPCH or CDH in interactions with external and internal partners and decision boards
- Contribute to the publication strategy of RLI/RLT compounds from the scientific standpoint
- May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- What you'll bring to the role:
- Nuclear medicine Physician/Medical Doctor (EU or US Board certified)
- Sophisticated knowledge and clinical training in oncology PET; Clinical practice experience 5 years preferred.
- Experience in Clinical Trials with a PET component
- Experience with Radioligand therapy
- A consistent track record to interpret, discuss and present data relating to clinical trial(s) with a Nuclear Medicine component
- Demonstrated ability to establish effective scientific partnerships with key partners
- Solid understanding of GCP, clinical trial design, statistics, regulatory and clinical development processes
Why consider Novartis?
- 769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you
