Medical Director/Exec Dir., Autoimmune Translational Medicine
- Basel, Switzerland
30 million! That is the estimated number of patients worldwide suffering from inflammatory arthritis. Join Novartis to help find the right drugs that transform and improve patients' lives all around the world.
You will join a team making significant impact on autoimmune diseases with high unmet medical need, taking new medicines into early-stage clinical trials: in many cases you will be the first to witness the effectiveness of a new medicine that may transform the lives of millions. Your medical and scientific leadership / expertise will significantly impacts the Novartis autoimmune drug development pipeline.
International family relocation is supported.
Your responsibilities will include:
• Medical / scientific contributor and leader of complex global cross-functional teams. Our successful drug discovery and development environment has close collaboration across Research, Clinical Research and Development.
• Major initiator of the Proof-of-Concept strategy and the early Clinical Development Plan. Develop and implement strategies for efficient, high value management of drug development projects leading to clinical Proof-of-Concept and competitiveness of compounds
• Develop and implement disease area and biomarker strategies: contribute effectively to the preclinical and clinical Disease Area strategies, project-specific Biomarker strategy, innovative target identification and in-licensing efforts resulting in a high quality preclinical and clinical portfolio
• Ensure full implementation of studies during the Proof-of-Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team, and direct or supervisory medical support for all pharmacokinetic studies
• Translational Medicine representative to Health Authorities in matters and meetings that focus on early exploratory development: negotiate effectively with Health Authority representatives on all aspects of Translational Medicine and obtain results favorable to Novartis. Translational Medicine representative to Translational Medicine/medically related experts and organizations, advancing the interests of Novartis by your knowledge, style and personal skill and enhancing the position of Novartis with these individuals and groups
• Contribute senior expertise to Research in support of target identification, selection, target validation and preclinical development of compounds. Review and evaluates cross-Disease Area activities at and beyond the early compound optimization stage. Provide clinical context and help design optimal preclinical studies
• Evaluate clinical centers and foster communication with crucial collaborating investigators. Interact effectively with external medical and non-medical leaders and be an internal Novartis expert leader in your scientific and clinical subspecialty field.
Matrix people responsibility per project: 5-8 cross-functional members from Translational Medicine plus other line functions per project team
Impact of this role?
• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds
• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions
• As a recognized expert in your field, you drive project team clinical strategies and bring global credibility across various Novartis Institutes and Divisions as well as country organizations
What you'll bring to the role:
• Board certified Rheumatologist (or similar relevant sub-specialty clinical training with directly relevant patient experience)
• PhD-level basic science. A completed relevant postdoctoral fellowship is strongly preferred
• Advanced / business-level / fluent English (oral and written)
• Recognized for your medical expertise: an experienced Clinician treating relevant patient groups at an academic medical center or private medical practice group
• Recognized for your scientific expertise: respected by colleagues internally and externally, you've made significant contributions to your field and created / established new concepts; you have a record of high quality publications in international scientific journals
• Experienced designing and conducting early phase clinical trials including for inflammatory arthritis, either from pharma/biotech; a senior role within a CRO responsible for the medical relationship and studies with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience ideally with Sponsors. 5+ years trial experience particularly in inflammatory arthritis preferred
• You are used to working independently and within teams including autoimmune disease research scientists and non-scientists on study planning and execution, demonstrating competence in a broad range of project and more strategic planning skills and leading complex cross-functional/matrix project teams
Your behavioural characteristics
• Demonstrated passion for treating patients and science
• 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 - we can hire Executive Director for those with careers that include significant senior Pharma early phase trial leadership.
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-Scientists drive innovative and cutting-edge science through the selection, profiling and effective global development of successful medicines, integrating clinical science into the discovery and preclinical development phase. Our Translational Medicine concepts are driven by medical needs of patients and the concept of personalized medicine, tailoring the drug, dose and dosing regimen to the patient so the clinical response is optimal in 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 with a project team including research, biomarkers, biostatistics, modeling & simulation, toxicology, technical experts and clinical trial teams.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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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