394807BR
Mar 19, 2024
USA
About the Role
Onsite
About the Role:
This exciting and influential role is accountable for the oversight, coordination and development of early viability assessments, global feasibility assessments (pre-IMB and trial feasibility), recruitment projections and allocation strategies for the assigned trials and programs. As a key member of the Global Clinical Operations sub-team, the Clinical Operations Program Associate Director provides precise oversight and ensure alignment with the overarching strategy and GCO operational position adding directly into the feasibility strategies. The COP AD’s scope of activities will also include pre-IMB project feasibility and/or early viability assessment, trial feasibility assessment, validation and refinement of trial allocation strategy, including scenario planning and risk management, and any re-feasibility assessments, as applicable.
Your Key Responsibilities:
Lead and conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials.
Serve as the point of contact for assigned program and trial feasibilities, leading the multidisciplinary feasibility teams to develop, validate and refine allocation strategy, including timelines, scenarios, and risk mitigation plans. Identify and resolve events in the indication landscape that represent operational risks for the execution of clinical trials within the given indication/program. Lead integration of regional and local indication strategies within global execution plans.
Partner closely with the country feasibility team to align on the end-to-end quality of feasibility product
Key contributor to the Operational Execution Plan:
a. Collection and analysis of internal and external data (i.e. local treatment standard of care, available treatment options approved/reimbursed, local prevalence and access to targeted populations) through analysis of clinical intelligence data describing the indication landscape including scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally, from external and internal research data sources including analysis of historical data related to site performance (data quality, start-up cycle time, patient enrollment), based on the clinical intelligence package received from the Health Insights Manager and other data sources
b. Defines an optimal geographic country footprint and proposed sites for participation in a clinical trial and supports COPH & GCO sub-team on final site allocation.
c. Designs and executes the feasibility process by developing feasibility assessment/survey, coordinates execution of feasibility at country level, evaluates prospective sites on their operational and medical capability to conduct the study, and provides a thorough analysis and summary of feasibility outcome to the GCO sub-team
d. Develops and proposes risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation.
Responsible for the creation and maintenance of patient enrollment forecast, at study levels
About the Role:
This exciting and influential role is accountable for the oversight, coordination and development of early viability assessments, global feasibility assessments (pre-IMB and trial feasibility), recruitment projections and allocation strategies for the assigned trials and programs. As a key member of the Global Clinical Operations sub-team, the Clinical Operations Program Associate Director provides precise oversight and ensure alignment with the overarching strategy and GCO operational position adding directly into the feasibility strategies. The COP AD’s scope of activities will also include pre-IMB project feasibility and/or early viability assessment, trial feasibility assessment, validation and refinement of trial allocation strategy, including scenario planning and risk management, and any re-feasibility assessments, as applicable.
Your Key Responsibilities:
Lead and conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials.
Serve as the point of contact for assigned program and trial feasibilities, leading the multidisciplinary feasibility teams to develop, validate and refine allocation strategy, including timelines, scenarios, and risk mitigation plans. Identify and resolve events in the indication landscape that represent operational risks for the execution of clinical trials within the given indication/program. Lead integration of regional and local indication strategies within global execution plans.
Partner closely with the country feasibility team to align on the end-to-end quality of feasibility product
Key contributor to the Operational Execution Plan:
a. Collection and analysis of internal and external data (i.e. local treatment standard of care, available treatment options approved/reimbursed, local prevalence and access to targeted populations) through analysis of clinical intelligence data describing the indication landscape including scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally, from external and internal research data sources including analysis of historical data related to site performance (data quality, start-up cycle time, patient enrollment), based on the clinical intelligence package received from the Health Insights Manager and other data sources
b. Defines an optimal geographic country footprint and proposed sites for participation in a clinical trial and supports COPH & GCO sub-team on final site allocation.
c. Designs and executes the feasibility process by developing feasibility assessment/survey, coordinates execution of feasibility at country level, evaluates prospective sites on their operational and medical capability to conduct the study, and provides a thorough analysis and summary of feasibility outcome to the GCO sub-team
d. Develops and proposes risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation.
Responsible for the creation and maintenance of patient enrollment forecast, at study levels
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:
Bachelors in life science/healthcare
5+ years of pharmaceutical clinical drug development experience (3+ years in planning/execution global clinical trials)
Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.
Possess strong, resourceful research skills to locate unusual information and have capacity to develop a deep domain specific knowledge base.
Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges as well as sources for therapeutic area data.
Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others.
Demonstrated experience in feasibility for global clinical trials.
Preferred Qualifications:
Advanced degree or equivalent education/degree in life sciences/ healthcare.
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
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,00 - $226,00/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: If this role is not suitable to your
experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Bachelors in life science/healthcare
5+ years of pharmaceutical clinical drug development experience (3+ years in planning/execution global clinical trials)
Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.
Possess strong, resourceful research skills to locate unusual information and have capacity to develop a deep domain specific knowledge base.
Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges as well as sources for therapeutic area data.
Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others.
Demonstrated experience in feasibility for global clinical trials.
Preferred Qualifications:
Advanced degree or equivalent education/degree in life sciences/ healthcare.
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
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,00 - $226,00/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: If this role is not suitable to your
experience or career goals but you wish to stay connected to learn 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
Development
GCO GDD
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular
No
