395020BR
März 20, 2024
Etats-Unis
About the Role
Remote Position
In this key role, the Clinical Program Lead will focus on Cardiovascular Development Program
• Actively contribute to successful trial performance from a clinical quality and recruitment perspective with a focus on clinical activities
• Drive US insights into Global Development trial concept sheets/protocols, Clinical Development Plans (CDP) and other relevant clinical documents.
• Co-Lead a US local cross-functional team to bring alignment of US MA (Medical Affairs), SSO (Study & Site Operations), and Development on US clinical development program strategy/tactics.
• Lead a smaller team of Clinical Research Medical Directors as direct reports
Your Key Responsibilities:
Clinical Development Strategy:
• As Country Clinical expert and member of core GCT (Global Clinical Team), supports GPCH (Global Program Clinical Head) or CDH (Clinical Development Head) and works closely with CDD (Clinical Development Director)/CDMD (Clinical Development Medical Director).
• Is accountable to bring continuous US strategic and executional input into CDPs/concept sheets/protocols/trials and provide insights for clinical / medical / patient perspective about trial design and programs for successful execution in US, inc. diversity.
• Co-Leads local cross-functional trial team Country Program Team (Local CPT) to ensure close collaboration and clear Roles & Responsibilities between SSO and MA to support GDD trials.
•Accountable for essential clinical/medical activities for Development and Biomedical Research priority clinical trials including feasibility, clinical/medical recruitment activities, protocol execution in US including answering protocol related questions and addressing critical safety related topics.
• Training
• Ensures program specific global Clinical Research Medical Advisor (CRMA) excellence and bidirectional communication from CRMA community to GCT (indication / protocol / competitor trainings, clinical medical recruitment activities, lessons learned etc.) with support from assigned regional CRMAs.
Stakeholder Management
• Act as the key scientific/clinical/medical point of contact for prioritized GDD clinical trial sites and provides knowledge on the company’s pipeline programs to these sites.
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 50% travel.
In this key role, the Clinical Program Lead will focus on Cardiovascular Development Program
• Actively contribute to successful trial performance from a clinical quality and recruitment perspective with a focus on clinical activities
• Drive US insights into Global Development trial concept sheets/protocols, Clinical Development Plans (CDP) and other relevant clinical documents.
• Co-Lead a US local cross-functional team to bring alignment of US MA (Medical Affairs), SSO (Study & Site Operations), and Development on US clinical development program strategy/tactics.
• Lead a smaller team of Clinical Research Medical Directors as direct reports
Your Key Responsibilities:
Clinical Development Strategy:
• As Country Clinical expert and member of core GCT (Global Clinical Team), supports GPCH (Global Program Clinical Head) or CDH (Clinical Development Head) and works closely with CDD (Clinical Development Director)/CDMD (Clinical Development Medical Director).
• Is accountable to bring continuous US strategic and executional input into CDPs/concept sheets/protocols/trials and provide insights for clinical / medical / patient perspective about trial design and programs for successful execution in US, inc. diversity.
• Co-Leads local cross-functional trial team Country Program Team (Local CPT) to ensure close collaboration and clear Roles & Responsibilities between SSO and MA to support GDD trials.
•Accountable for essential clinical/medical activities for Development and Biomedical Research priority clinical trials including feasibility, clinical/medical recruitment activities, protocol execution in US including answering protocol related questions and addressing critical safety related topics.
• Training
• Ensures program specific global Clinical Research Medical Advisor (CRMA) excellence and bidirectional communication from CRMA community to GCT (indication / protocol / competitor trainings, clinical medical recruitment activities, lessons learned etc.) with support from assigned regional CRMAs.
Stakeholder Management
• Act as the key scientific/clinical/medical point of contact for prioritized GDD clinical trial sites and provides knowledge on the company’s pipeline programs to these sites.
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 50% travel.
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
• Scientific degree M.D (preferred); Pharm.D or PhD. Subspecialty training desirable in, Cardiology
• Training in relevant aspects of clinical drug development including GCP, Country regulatory requirements and data privacy laws.
• Superior leadership and collaboration skills to be able to effectively communicate, motivate a cross-functional team, lead alignment across line functions and delegate responsibilities.
• Agility to move fast across different therapeutic areas and indications.
• Ideally, 7 plus years clinical development experience in the pharmaceutical industry or in clinical practice. Including sound understanding of the overall clinical development process, study designs and ICH/GCP principles.
• Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial.
• Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
• Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues.
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.
The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400/year (MD range) and $222,400 and $333,600/year (non-MD range); 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/
• Training in relevant aspects of clinical drug development including GCP, Country regulatory requirements and data privacy laws.
• Superior leadership and collaboration skills to be able to effectively communicate, motivate a cross-functional team, lead alignment across line functions and delegate responsibilities.
• Agility to move fast across different therapeutic areas and indications.
• Ideally, 7 plus years clinical development experience in the pharmaceutical industry or in clinical practice. Including sound understanding of the overall clinical development process, study designs and ICH/GCP principles.
• Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial.
• Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
• Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues.
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.
The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400/year (MD range) and $222,400 and $333,600/year (non-MD range); 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/
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
Etats-Unis
East Hanover, NJ
Novartis Pharmaceuticals
Recherche & Développement
Full Time
Regular
No
