Novartis
Clinical Development Medical Director - Immunology, Rheumatology
Novartis, East Hanover, New Jersey, us, 07936
Summary
As 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 projects(s) from an end-to-end clinical development perspective. Together with your team, you will drive execution of the clinical development plan. You will harness the strengths of a diverse team and create a collaborative and inclusive work environment You are eager to empower your team members, in a complex matrix environment and adjust quickly to business needs.
About the Role
Your 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 development of disease clinical standards for new disease areas
As a medical specialist, supporting 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 diligences together with other medical matters, as needed
Minimum Requirements:
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
Desirable:
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. 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
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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 [email protected] 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.
Division
Development
Business Unit
Innovative Medicines
Location
USA
Site
East Hanover
Company / Legal Entity
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Alternative Location 1
Cambridge (USA), USA
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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As 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 projects(s) from an end-to-end clinical development perspective. Together with your team, you will drive execution of the clinical development plan. You will harness the strengths of a diverse team and create a collaborative and inclusive work environment You are eager to empower your team members, in a complex matrix environment and adjust quickly to business needs.
About the Role
Your 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 development of disease clinical standards for new disease areas
As a medical specialist, supporting 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 diligences together with other medical matters, as needed
Minimum Requirements:
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
Desirable:
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. 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
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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 [email protected] 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.
Division
Development
Business Unit
Innovative Medicines
Location
USA
Site
East Hanover
Company / Legal Entity
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Alternative Location 1
Cambridge (USA), USA
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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