Job Description Over 2 million! That’s the number of people worldwide who currently rely on dialysis or kidney transplant to survive. This number may represent less than 10% of the actual number requiring treatment for kidney related illnesses.
As a Translational Medicine Expert / Medical Director, you will provide medical and scientific expertise that drives the success of global clinical studies and implement strategies to achieve clinical Proof of Concept in the area of Nephrology, Transplantation, and Inflammation.
1. Translational Medicine:
- In collaboration with your Translational Medicine Head or more experienced Translational Medicine Expert, 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 Proof of Concept to drive implementation of the Proof of Concept strategy; participate in project teams through the program life cycle from Target Review to registration
- Responsible for clinical portions of the Integrated Development Plan through Proof of Concept
- Responsible for implementation of studies during Proof of Concept 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 in Proof of Concept studies
- 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 approach to Proof of Concept
- Evaluate clinical centers and foster communication with crucial collaborating investigators
- Oversee publication and external presentation of Proof of Concept clinical study results
2. Accountable for compound related Biomarker strategies; work closely with Biomarker Expert in implementation
3. In collaboration with research scientists, identify, develop and implement strategy for pre-clinical support of program-related objectives. This includes assessment of medical need, proposal of clinical development pathways, and review of pre-clinical data for clinical implications, and other relevant activities
4. Participate in team presentations to health authorities as the Translational Medicine expert
5. Prepare and implement Disease Area or project-specific training and educational programs for project team colleagues from Translational Medicine and other line functions. Mentor Translational Medicine colleagues on scientific, clinical, and drug development issues
6. Contribute to initiatives that drive innovation, quality, and efficiency across Translational Medicine
- This position is written for Director - we can also hire Associate Director for those with training and experience not yet at Director-level. An Associate Director role profile will be provided as appropriate.
- The position can be based in Basel (Switzerland) or Cambridge, Massachusetts (USA): please state your location preference within your application letter. Basel is preferred for co-location with the research Disease Area scientists
Minimum requirements - 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 current Nephrology team
- Expertise in genetically-inherited kidney / inflammasome / inflammatory diseases; alternatively cell therapies / haematologic 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
ABOUT TRANSLATIONAL MEDICINE
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 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 IIa studies). Our Translational Medicine Experts are part of preclinical project teams in all drug discovery phases and help design the pathway for First in Human 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, modeling and simulation, toxicology, technical experts and the clinical trial teams.
After the completion of a successful Phase IIa study the drug progresses to full Development for Phase IIb and Phase III study design and further drug development. Translational Medicine Experts with an interest in profiling will often continue as members of the global project team to characterize the clinical pharmacology, the mode of action, the biomarker response of a compound, look for new potential indications, contribute to the drug approval process and profile a new compound further in the market.
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.
Business UnitTranslational Medicine
Company/Legal EntityNovartis Pharma AG
Functional AreaResearch & Development
Job TypeFull Time