387160BR
Jan 18, 2024
Switzerland
About the Role
Over 2 million! That’s the number of people worldwide currently relying on dialysis or kidney transplants to survive. However, this number represent less than 10% of the actual number requiring treatment for their kidney diseases.
As a Translational Medicine Expert (TME), you will provide medical and scientific expertise that drives the success of early drug development, global clinical studies, and strategies to achieve clinical Proof-of-Concept in the Nephrology disease area, and to progress towards new treatments for unmet medical needs.
The position can be in Basel (Switzerland) or Cambridge, Massachusetts (USA); please state your preference within your application letter. Basel is preferred for co-location with most of the disease area scientists.
About Translational Medicine at Novartis
Translational Medicine is a global group of scientists and physicians working at the pre-clinical and early clinical stage of drug discovery.
Our physician-scientist discovery & profiling (TMDP) group drives innovative and cutting–edge science from discovery to the market through the selection, profiling and effective global development of successful medicines. The group closes the gap between preclinical research and clinical development and integrates clinical science into the discovery and preclinical development phase. Our Translational Medicine concepts are driven by medical needs of the patient and the concept of personalized medicine, tailoring the drug, its dose and dosing regimen in such way to the patient that the clinical response is optimal in terms of efficacy and safety.
We focus from identification of drug targets (molecular pathways relevant to disease) up to the completion of Proof-of-Concept (Phase 2a studies). Our Translational Medicine Experts (TME) are part of preclinical project teams in all drug discovery phases and help design the pathway for First in Human (FIH) studies (healthy volunteer) that bridge to studies in the patient population. They have the comprehensive responsibility for designing and executing the early clinical drug development phase together with a project team from researcher, biomarkers, biostatistics, modelling & simulation, toxicology, technical experts and the clinical trial teams.
After the completion of a successful Phase 2a study the drug progresses to full development for Phase 2b and Phase 3 study design and further drug development.
Your role in Translational Medicine
- In collaboration with your Translational Medicine Head and other line function experts, develop high value decision-strategies for the Translational Medicine component of drug development projects through the Proof-of-Concept phase
- Lead global project teams through Phase 2 to drive implementation of the project strategy; participate in cross-functional project meetings through the program life cycle from target review to registration
- Responsible for clinical portions of the Integrated Development Plan through Phase 2
- Responsible for implementation of early clinical studies by providing medical and scientific leadership and expertise to all line functions on the project team; this may include methodology studies to identify and validate novel endpoints for early decision making
- Participate in analysis of studies and present results to relevant decision boards
- Medical monitor for one or more global clinical studies
- Communicate clinical team matters to project teams and relevant decision boards
- Convene relevant (internal and external) leaders together to consider the proposed development strategy
- Evaluate clinical centers and foster communication with collaborating investigators
- Oversee publication and external presentation of clinical study results
- Accountable for compound related biomarker strategies in close collaboration with biomarker experts
- In collaboration with research scientists, identify, develop and implement strategy for pre-clinical support of program-related objectives; this may include assessment of medical need, proposal of clinical development pathways, and review of pre-clinical data for clinical implications, and other relevant activities
- Participate in team presentations to health authorities as clinical development expert
- Prepare and implement disease area or project-specific trainings and educational programs for colleagues from Translational Medicine and other line functions; mentor Translational Medicine colleagues on scientific, clinical, and drug development issues
- Contribute to initiatives that drive innovation, quality, and efficiency across Translational Medicine
As a Translational Medicine Expert (TME), you will provide medical and scientific expertise that drives the success of early drug development, global clinical studies, and strategies to achieve clinical Proof-of-Concept in the Nephrology disease area, and to progress towards new treatments for unmet medical needs.
The position can be in Basel (Switzerland) or Cambridge, Massachusetts (USA); please state your preference within your application letter. Basel is preferred for co-location with most of the disease area scientists.
About Translational Medicine at Novartis
Translational Medicine is a global group of scientists and physicians working at the pre-clinical and early clinical stage of drug discovery.
Our physician-scientist discovery & profiling (TMDP) group drives innovative and cutting–edge science from discovery to the market through the selection, profiling and effective global development of successful medicines. The group closes the gap between preclinical research and clinical development and integrates clinical science into the discovery and preclinical development phase. Our Translational Medicine concepts are driven by medical needs of the patient and the concept of personalized medicine, tailoring the drug, its dose and dosing regimen in such way to the patient that the clinical response is optimal in terms of efficacy and safety.
We focus from identification of drug targets (molecular pathways relevant to disease) up to the completion of Proof-of-Concept (Phase 2a studies). Our Translational Medicine Experts (TME) are part of preclinical project teams in all drug discovery phases and help design the pathway for First in Human (FIH) studies (healthy volunteer) that bridge to studies in the patient population. They have the comprehensive responsibility for designing and executing the early clinical drug development phase together with a project team from researcher, biomarkers, biostatistics, modelling & simulation, toxicology, technical experts and the clinical trial teams.
After the completion of a successful Phase 2a study the drug progresses to full development for Phase 2b and Phase 3 study design and further drug development.
Your role in Translational Medicine
- In collaboration with your Translational Medicine Head and other line function experts, develop high value decision-strategies for the Translational Medicine component of drug development projects through the Proof-of-Concept phase
- Lead global project teams through Phase 2 to drive implementation of the project strategy; participate in cross-functional project meetings through the program life cycle from target review to registration
- Responsible for clinical portions of the Integrated Development Plan through Phase 2
- Responsible for implementation of early clinical studies by providing medical and scientific leadership and expertise to all line functions on the project team; this may include methodology studies to identify and validate novel endpoints for early decision making
- Participate in analysis of studies and present results to relevant decision boards
- Medical monitor for one or more global clinical studies
- Communicate clinical team matters to project teams and relevant decision boards
- Convene relevant (internal and external) leaders together to consider the proposed development strategy
- Evaluate clinical centers and foster communication with collaborating investigators
- Oversee publication and external presentation of clinical study results
- Accountable for compound related biomarker strategies in close collaboration with biomarker experts
- In collaboration with research scientists, identify, develop and implement strategy for pre-clinical support of program-related objectives; this may include assessment of medical need, proposal of clinical development pathways, and review of pre-clinical data for clinical implications, and other relevant activities
- Participate in team presentations to health authorities as clinical development expert
- Prepare and implement disease area or project-specific trainings and educational programs for colleagues from Translational Medicine and other line functions; mentor Translational Medicine colleagues on scientific, clinical, and drug development issues
- Contribute to initiatives that drive innovation, quality, and efficiency across Translational Medicine
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
What you’ll bring to the role
- Medical Degree, Board certified Nephrologist
- PhD-level basic science supported with high quality publications; a completed postdoctoral fellowship is strongly preferred
- Adult Nephrology expertise is preferred to bring additional skills to the team
- Expertise in genetically inherited kidney / inflammasome / inflammatory diseases; alternatively, cell therapies / rheumatologic diseases
- Experienced clinician treating relevant patient groups at an academic medical center or private medical practice group
- Experience performing in a similar role within an Pharmaceutical research company is preferred, otherwise a Clinical Research Organization or academic medical center
- Significant evidence of successful collaboration with expert disease research scientists
- Used to leading complex cross-functional/matrix project teams
- Advanced/business-level/fluent English
Your behavioural characteristics
- Strategic thinker: you have created major innovations, networked with and influenced external medical leaders with your clear and logical presentation of complex strategic issues
- Results-driven self-starter and decision taker
- Strong cooperative team player, flexible in a changing environment
- Good planning, prioritisation, problem solving and organisational skills
- Resilient, energetic, and enthusiastic; responding constructively to challenging new ideas and input
This position is written for Director level; however, we can hire Associate Director that may have less established scientific and/or clinical trial experience but has already demonstrated new thinking/innovative approaches within their career so far, as well as more experienced Executive Directors.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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.
- Medical Degree, Board certified Nephrologist
- PhD-level basic science supported with high quality publications; a completed postdoctoral fellowship is strongly preferred
- Adult Nephrology expertise is preferred to bring additional skills to the team
- Expertise in genetically inherited kidney / inflammasome / inflammatory diseases; alternatively, cell therapies / rheumatologic diseases
- Experienced clinician treating relevant patient groups at an academic medical center or private medical practice group
- Experience performing in a similar role within an Pharmaceutical research company is preferred, otherwise a Clinical Research Organization or academic medical center
- Significant evidence of successful collaboration with expert disease research scientists
- Used to leading complex cross-functional/matrix project teams
- Advanced/business-level/fluent English
Your behavioural characteristics
- Strategic thinker: you have created major innovations, networked with and influenced external medical leaders with your clear and logical presentation of complex strategic issues
- Results-driven self-starter and decision taker
- Strong cooperative team player, flexible in a changing environment
- Good planning, prioritisation, problem solving and organisational skills
- Resilient, energetic, and enthusiastic; responding constructively to challenging new ideas and input
This position is written for Director level; however, we can hire Associate Director that may have less established scientific and/or clinical trial experience but has already demonstrated new thinking/innovative approaches within their career so far, as well as more experienced Executive Directors.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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.
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? https://www.novartis.com/about/strategy/people-and-culture
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Biomedical Research
Translational Medicine
Switzerland
Basel
Novartis Pharma AG
Research & Development
Full Time
Regular
No
387160BR