Novartis Farmacéutica
Clinical Development Medical Director - Immunology, Rheumatology
Novartis Farmacéutica, Hanover, Massachusetts, us, 02340
Clinical Development Medical Director - Immunology, RheumatologyJob ID: REQ-10010088
Jul 09, 2024
Location: USA
SummaryAs the Clinical Development Medical Director (CDMD) Immunology, you will lead clinical teams dedicated to autoimmune rheumatic disease development programs in indications of lupus, including both systemic lupus erythematosus and lupus nephritis, through all study phases from inception/design to database lock and read-out. Core responsibilities include planning and management of the assigned clinical project(s) from an end-to-end clinical development perspective. Together with your team, you will drive execution of the clinical development plan, harnessing the strengths of a diverse team to create a collaborative and inclusive work environment.
About the RoleYour key responsibilities:
Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
Lead development of clinical sections of trial and program level regulatory documents.
Drive execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates.
Support the Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues.
Support the Clinical Development Head by providing medical input into the Clinical Development Plan, Integrated Development Plan, and Clinical Trial Protocol reviews, and contributing to the development of disease clinical standards for new disease areas.
As a medical specialist, support the GPCH or CDH in interactions with external and internal partners and decision boards.
May work with Novartis Biomedical Research/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligence together with other medical matters, as needed.
MD or equivalent medical degree is required, in addition to a proven track record of clinical experience in and scientific contributions to your field of expertise.
Training or working experience in one or more of the following:
- Rheumatology or clinical immunology
- Lupus clinical trial experience (systemic lupus erythematosus and/or lupus nephritis)
- B cell-depleting biologics
3+ years minimum in clinical research or drug development in immunology/inflammation.
Working knowledge in the area of Immunology and Inflammation with ability to interpret, discuss and present efficacy (clinical, biomarker) and safety data relating to clinical trials.
Understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
Availability of, and readiness to leverage scientific and clinical networks to establish scientific partnerships with key collaborators.
Ability to expertly lead independent data monitoring committees and phase 2b/3 advisory boards.
Clinical practice experience 4+ years (including residency in rheumatology or clinical immunology).
Previous global people management experience in clinical trial settings is preferred, though this may include management in a matrix environment.
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 to achieve breakthroughs that change patients’ lives.
Accessibility & Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Jul 09, 2024
Location: USA
SummaryAs the Clinical Development Medical Director (CDMD) Immunology, you will lead clinical teams dedicated to autoimmune rheumatic disease development programs in indications of lupus, including both systemic lupus erythematosus and lupus nephritis, through all study phases from inception/design to database lock and read-out. Core responsibilities include planning and management of the assigned clinical project(s) from an end-to-end clinical development perspective. Together with your team, you will drive execution of the clinical development plan, harnessing the strengths of a diverse team to create a collaborative and inclusive work environment.
About the RoleYour key responsibilities:
Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
Lead development of clinical sections of trial and program level regulatory documents.
Drive execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates.
Support the Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues.
Support the Clinical Development Head by providing medical input into the Clinical Development Plan, Integrated Development Plan, and Clinical Trial Protocol reviews, and contributing to the development of disease clinical standards for new disease areas.
As a medical specialist, support the GPCH or CDH in interactions with external and internal partners and decision boards.
May work with Novartis Biomedical Research/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligence together with other medical matters, as needed.
MD or equivalent medical degree is required, in addition to a proven track record of clinical experience in and scientific contributions to your field of expertise.
Training or working experience in one or more of the following:
- Rheumatology or clinical immunology
- Lupus clinical trial experience (systemic lupus erythematosus and/or lupus nephritis)
- B cell-depleting biologics
3+ years minimum in clinical research or drug development in immunology/inflammation.
Working knowledge in the area of Immunology and Inflammation with ability to interpret, discuss and present efficacy (clinical, biomarker) and safety data relating to clinical trials.
Understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
Availability of, and readiness to leverage scientific and clinical networks to establish scientific partnerships with key collaborators.
Ability to expertly lead independent data monitoring committees and phase 2b/3 advisory boards.
Clinical practice experience 4+ years (including residency in rheumatology or clinical immunology).
Previous global people management experience in clinical trial settings is preferred, though this may include management in a matrix environment.
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 to achieve breakthroughs that change patients’ lives.
Accessibility & Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
#J-18808-Ljbffr