384967BR
Nov 21, 2023
USA
About the Role
INTERNAL ROLE TITLE: Clinical Program Leader
LOCATION: Cambridge, MA
#LI-Onsite
About this role: Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements.
Key responsibilities:
• Acts as a clinical leader for a region / large countries or strategic sites responsible for assigned clinical program(s) -driving medical strategy implementation and operational deliverables for development and marketed products in a defined therapeutic area.
• Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program and/or programs.
• Ensures effective cross-functional communications to align with global strategy
• Leads development of clinical sections of trial and program level regulatory documents
• Drives execution of the section of the clinical program in partnership with global line functions.
• Supports the clinical research leaders by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas
• Acts as the medical expert, engages interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS collaborators.
• Contributes to medical/scientific training of relevant Novartis collaborators. May serve as speaker for franchise medical/scientific training -May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
• Develops high potential talents for succession positions to ensure business continuity.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)
The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400 / year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.
LOCATION: Cambridge, MA
#LI-Onsite
About this role: Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements.
Key responsibilities:
• Acts as a clinical leader for a region / large countries or strategic sites responsible for assigned clinical program(s) -driving medical strategy implementation and operational deliverables for development and marketed products in a defined therapeutic area.
• Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program and/or programs.
• Ensures effective cross-functional communications to align with global strategy
• Leads development of clinical sections of trial and program level regulatory documents
• Drives execution of the section of the clinical program in partnership with global line functions.
• Supports the clinical research leaders by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas
• Acts as the medical expert, engages interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS collaborators.
• Contributes to medical/scientific training of relevant Novartis collaborators. May serve as speaker for franchise medical/scientific training -May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
• Develops high potential talents for succession positions to ensure business continuity.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)
The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400 / year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.
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
Essential Requirements:
• This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will not require travel as defined by the business (domestic and/or international).
• MD or DO degree required. MD, PhD, board certified Oncologist; thoracic oncology expertise strongly preferred. Laboratory-based science training is preferred.
• 3-5 years of pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in oncology and clinical study experience is required.
• Ability to interpret preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)
• Solid understanding of Pharmacokinetic / Pharmacodynamic and biostatistics to clinical development and clinical trials
• Proven track record to analyze and interpret efficacy and safety data relating to oncology
• Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology
• Excellent medical/scientific writing skills
• Effective written and oral communication skills
• Excellent personal ethical integrity and a dedication to improving the outcomes for patients with malignancies
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
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.
Accessibility and 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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.
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
• This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will not require travel as defined by the business (domestic and/or international).
• MD or DO degree required. MD, PhD, board certified Oncologist; thoracic oncology expertise strongly preferred. Laboratory-based science training is preferred.
• 3-5 years of pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in oncology and clinical study experience is required.
• Ability to interpret preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)
• Solid understanding of Pharmacokinetic / Pharmacodynamic and biostatistics to clinical development and clinical trials
• Proven track record to analyze and interpret efficacy and safety data relating to oncology
• Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology
• Excellent medical/scientific writing skills
• Effective written and oral communication skills
• Excellent personal ethical integrity and a dedication to improving the outcomes for patients with malignancies
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
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.
Accessibility and 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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.
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
Biomedical Research
TCO NIBR
USA
Cambridge, MA
NIBRI
Research & Development
Full Time
Regular
No
