388658BR
Mar 21, 2024
USA
About the Role
Hybrid: East Hanover, New Jersey
#LI-Hybrid
Novartis Oncology has a renowned history in oncology and developing transformative radioligand therapies for patients.
As our Clinical Development Medical Director, Nuclear Medicine, you will be the clinical leader of defined program-level activities such as submission activities, preparing briefing books or transformative trials, under the leadership of the Global Program Clinical Head. You may lead a section of a clinical program, an indication, new formulation, or specific development phase.
Your Key Responsibilities:
• Provide clinical leadership and medical & strategic input for all clinical results in the assigned project or a section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Clinical Development Plans, clinical data review, program standards, clinical components of regulatory documents/registration dossiers, radioligand therapy related education and publications
• Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• Drive execution of the section of the clinical program in partnership with line functions, assigned Clinical Operations Program Head, and regional/country medical associates if applicable
• Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert
• May be the Program Manager of other associates. Support the GPCH in ensuring safety of the molecule for the assigned section, may be a core member of the Safety Management Team, and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs) and other safety related documents) in collaboration with Patient Safety
• Work with the Clinical Development Head (CDH) providing medical input into the Development Plan and Clinical Trial Protocol reviews and driving development of disease clinical standards for new disease areas.
• Support the GPCH or CDH in interactions with external partners (authorities, opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcome Research), and decision boards
• Work with Biomedical Research (BR)/Translational Medical Sciences to drive the Research-Development-Commercial continuum and with Business Development & Licensing
The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity). Please note that this role would not provide relocation as a result. If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
#LI-Hybrid
Novartis Oncology has a renowned history in oncology and developing transformative radioligand therapies for patients.
As our Clinical Development Medical Director, Nuclear Medicine, you will be the clinical leader of defined program-level activities such as submission activities, preparing briefing books or transformative trials, under the leadership of the Global Program Clinical Head. You may lead a section of a clinical program, an indication, new formulation, or specific development phase.
Your Key Responsibilities:
• Provide clinical leadership and medical & strategic input for all clinical results in the assigned project or a section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Clinical Development Plans, clinical data review, program standards, clinical components of regulatory documents/registration dossiers, radioligand therapy related education and publications
• Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• Drive execution of the section of the clinical program in partnership with line functions, assigned Clinical Operations Program Head, and regional/country medical associates if applicable
• Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert
• May be the Program Manager of other associates. Support the GPCH in ensuring safety of the molecule for the assigned section, may be a core member of the Safety Management Team, and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs) and other safety related documents) in collaboration with Patient Safety
• Work with the Clinical Development Head (CDH) providing medical input into the Development Plan and Clinical Trial Protocol reviews and driving development of disease clinical standards for new disease areas.
• Support the GPCH or CDH in interactions with external partners (authorities, opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcome Research), and decision boards
• Work with Biomedical Research (BR)/Translational Medical Sciences to drive the Research-Development-Commercial continuum and with Business Development & Licensing
The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity). Please note that this role would not provide relocation as a result. If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
Diversity & Inclusion / EEO
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Role Requirements
Required:
• MD or equivalent medical degree required. Extensive knowledge and clinical training in nuclear medicine. Nuclear Medicine Physician (EU or US Board certified)
• 5+ years direct involvement in clinical research or drug development in an academic or industry environment or equivalent, spanning clinical activities preferably in Phases I through IV. Having contributed to and accomplished in all aspects of conducting clinical trials in a global/matrix environment in pharmaceutical industry or equivalent
• Clinical experience in oncology PET or equivalent
Desired:
• Experience with radioligand therapy
• Detailed knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
• People management experience preferred; this may include management in a matrix environment
• Excellent negotiation, conflict resolution and communication skills (written and oral).
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.
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
Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $257,600 - $386,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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
• MD or equivalent medical degree required. Extensive knowledge and clinical training in nuclear medicine. Nuclear Medicine Physician (EU or US Board certified)
• 5+ years direct involvement in clinical research or drug development in an academic or industry environment or equivalent, spanning clinical activities preferably in Phases I through IV. Having contributed to and accomplished in all aspects of conducting clinical trials in a global/matrix environment in pharmaceutical industry or equivalent
• Clinical experience in oncology PET or equivalent
Desired:
• Experience with radioligand therapy
• Detailed knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
• People management experience preferred; this may include management in a matrix environment
• Excellent negotiation, conflict resolution and communication skills (written and oral).
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.
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
Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $257,600 - $386,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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
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
Development
CLINICAL DEVELOPMENT DEV
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular
No
