360267BR
Feb 17, 2023
Switzerland
Job Description
13! The number of medicines Cardio Renal Metabolic diseases currently in development at Novartis.
Novartis is deeply committed to transforming the lives of people living with cardiovascular, renal and metabolic diseases. 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 people’s 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
The Clinical Development Medical Director (CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As CDMD, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
Your responsibilities will include, but are not limited to:
• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Leading development of clinical sections of trial and program level regulatory documents
• Driving execution the assigned clinical 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 medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
• 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.
Novartis is deeply committed to transforming the lives of people living with cardiovascular, renal and metabolic diseases. 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 people’s 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
The Clinical Development Medical Director (CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As CDMD, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
Your responsibilities will include, but are not limited to:
• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Leading development of clinical sections of trial and program level regulatory documents
• Driving execution the assigned clinical 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 medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
• 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.
Diversity & Inclusion / EEO
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 bring to the role:
MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area (pediatric nephrology) ; Clinical practice experience 4 years (including residency)
Minimum of 7 years of experience in clinical research or drug development
Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
• Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
• Demonstrated ability to establish effective scientific partnerships with key stakeholders
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Previous global people management experience is preferred, though this may include management in a matrix environment.
**Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. 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 brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area (pediatric nephrology) ; Clinical practice experience 4 years (including residency)
Minimum of 7 years of experience in clinical research or drug development
Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
• Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
• Demonstrated ability to establish effective scientific partnerships with key stakeholders
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Previous global people management experience is preferred, though this may include management in a matrix environment.
**Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. 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 brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Global Drug Development
CARDIO-RENAL-METAB GDD
Switzerland
Basel
Novartis Pharma AG
Research & Development
Full Time
Regular
No
360267BR