Publié: 05 avril 2024
Clinical Development Medical Director - Renal
Basel
100%
Durée indéterminée
25 offres d'emploi Directrice business development à Basel
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Clinical Development Medical Director - Renal
Novartis AG
Date de publication :
05 avril 2024Taux d'activité :
100%Type de contrat :
Durée indéterminéeLieu de travail :
Basel
Clinical Development Medical Director - Renal
About the Role
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 in Renal development, 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:
• Providing clinical leadership and strategic medical input for all clinical results 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 CDMD in Renal development, 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:
• Providing clinical leadership and strategic medical input for all clinical results 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
Role Requirements
What you bring to the role:
• MD/medical degree is required in addition to sophisticated knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in Renal disease area preferred
• Minimum of 7 years of proven 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, driving, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
• Solid understanding of Renal disease area is required, with validated 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 collaborators
• Solid understanding 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.
Final job title and associated responsibilities will be commensurate with the successful candidates’ level of expertise (Senior/Director/Associate)
****Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• MD/medical degree is required in addition to sophisticated knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in Renal disease area preferred
• Minimum of 7 years of proven 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, driving, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
• Solid understanding of Renal disease area is required, with validated 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 collaborators
• Solid understanding 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.
Final job title and associated responsibilities will be commensurate with the successful candidates’ level of expertise (Senior/Director/Associate)
****Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external)