SUMMARY

~ Überwacht die Planung, Durchführung und Interpretation der Forschung klinischer Studien, der Datenerfassungsaktivitäten und des klinischen Betriebs. Etabliert und genehmigt wissenschaftliche Methoden für das Design und die Implementierung von klinischen Protokollen, Datenerfassungssystemen und Abschlussberichten. Unterstützung neuer und laufender klinischer Forschung und klinischer Studien und Gewährleistung einer effizienten und zeitnahen Bearbeitung von Vertraulichkeitsvereinbarungen und klinischen Vereinbarungen

MINIMUM REQUIREMENTS :

What you’ll bring to the role:

• MD or MD/PhD, or MD with doctoral thesis in relevant field (e.g., Nephrology, Acute/Critical Care, Hepatology, Inflammation, Rare Genetic Diseases).
• Board certification and clinical experience in Nephrology, Acute Care Medicine / Anesthesiology, Hepatology, Internal Medicine, Immunology, or related field.
• Recognized physician-scientist expertise as evidenced by publication and/or significant contributions to the field over time.
• Demonstrated passion for science driving innovation and clinical discovery with excellent written and oral communication/presentation skills.
• At least 3 years’ experience in a pharmaceutical/biotech company, clinical research organization, or academic medical center, or related experience.
• Able to work independently as outlined above, commensurate with the level of role.

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As Translational Medicine Expert, major accountabilities include:

• Develop and work with teams to develop and implement strategies for the TM component of drug development projects from Research to Development and Commercialization (RDC) in single or multiple indications, including indication expansion projects.
• Act as key leader in developing Phase 1/2/3 and post-approval profiling strategy for drug programs.
• Lead study-specific teams/ clinical trial teams in partnership with other line functions and serve as TM representative on Global Program Teams (GPT).
• Provide support for dose selection, study design and other clinical pharmacology matters throughout the development cycle.
• Oversee conduct and interpretation of studies supporting pivotal trials, such as special populations, drug-drug interactions, mechanism of action assessments, Pediatric Investigational Plan, etc.
• Participate in Corporate & Business Development (C&BD) teams as the TM representative.
• Represent TM aspects to Health Authorities and other stakeholders.
• Oversee publication strategy for TM studie

ABOUT THE ROLE

As TME, you will become part of a group of physician scientists responsible for all early clinical development plans and studies through first in human, first in disease, new diseases, translational research and profiling activities, and clinical pharmacology studies.
You will be a member of the broader Translational Medicine, Profiling and Discovery (TMDP) group, accountable for overall department goals in all disease areas, helping to lead continuous improvement across the department, and enhancing the culture of TM.
You will also be a key bridge between Research and Late-Phase Development and Commercial colleagues across the Novartis Research-Development-Commercial (RDC) Continuum.

As Translational Medicine Expert, major accountabilities include:

• Develop and work with teams to develop and implement strategies for the TM component of drug development projects from Research to Development and Commercialization (RDC) in single or multiple indications, including indication expansion projects.
• Act as key leader in developing Phase 1/2/3 and post-approval profiling strategy for drug programs.
• Lead study-specific teams/ clinical trial teams in partnership with other line functions and serve as TM representative on Global Program Teams (GPT).
• Provide support for dose selection, study design and other clinical pharmacology matters throughout the development cycle.
• Oversee conduct and interpretation of studies supporting pivotal trials, such as special populations, drug-drug interactions, mechanism of action assessments, Pediatric Investigational Plan, etc.
• Participate in Corporate & Business Development (C&BD) teams as the TM representative.
• Represent TM aspects to Health Authorities and other stakeholders.
• Oversee publication strategy for TM studies

What you’ll bring to the role:

• MD or MD/PhD, or MD with doctoral thesis in relevant field (e.g., Nephrology, Acute/Critical Care, Hepatology, Inflammation, Rare Genetic Diseases).
• Board certification and clinical experience in Nephrology, Acute Care Medicine / Anesthesiology, Hepatology, Internal Medicine, Immunology, or related field.
• Recognized physician-scientist expertise as evidenced by publication and/or significant contributions to the field over time.
• Demonstrated passion for science driving innovation and clinical discovery with excellent written and oral communication/presentation skills.
• At least 3 years’ experience in a pharmaceutical/biotech company, clinical research organization, or academic medical center, or related experience.
• Able to work independently as outlined above, commensurate with the level of role