Director, Clinical Process Excellence and Learning Strategy
Working with UsChallenging.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
Functional Area Description The Director, Clinical Process Excellence and Learning Strategy reports to the Senior Director of the Clinical Center of Excellence.
The Clinical Center of Excellence department serves all of Clinical Research and Development across all Therapeutic Areas with the objective to enhance clinical capabilities within the OneClinical organization and optimize ways of operating with a focus on Innovation, Consistency and Quality across the enterprise.
The CCoE serves as the operating bridge between the multiple Therapeutic Areas striving to build a culture of excellence.
The Director, Clinical Process Excellence and Learning Strategy drives all aspects of training and identified areas of learnings as well as onboarding for the OneClinical organization by interfacing and providing guidance to clinical leadership, and clinical teams as appropriate.
This role serves as the primary contact and advisor for all aspects of training, learning, and compliance within the Clinical Development organization.
This role works closely with cross-functional partners, as applicable, to ensure continuous improvement of processes and highest quality standards.
The Director, Clinical Process Excellence and Learning Strategy is accountable to drive process optimization and improvement following standard methodology, ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the Good Clinical Practices document hierarchy.
Position Summary / Objectives The Director, Clinical Process Excellence and Learning Strategy supports and enables OneClinical compliance objectives through the development of the technical training profiles and requirements, based on the activities identified through the clinical Quality Management System (QMS), audit and inspection outcomes, to assure the processes are built/adapted as needed in support of quality by design principles.
This role is accountable for the development, implementation, maintenance, and continuous improvement of role-based curricula (RBC) and certification of study team members across the Research and Development organizations to ensure compliance to GCP requirements in the conduct of clinical trials end to end.
The Director, Clinical Process Excellence and Learning Strategy will be responsible for aligning with key clinical leadership stakeholders including Clinical Therapeutic Heads, Clinical Development Heads and Clinical Science Heads across all Therapeutic Areas in drug development to align training roles with business needs and goals, as well as build capacity to upskill current workforce and train new employees quickly and effectively.
The Director, Clinical Process Excellence and Learning Strategy will lead the development and delivery of educational and training programs focused on advancing clinical development capabilities while developing a high functioning community of practitioners as well as lead initiatives focused on enhancing clinical development innovation and efficiency.
Additionally, this role will continuously evaluate opportunities to make learning user friendly and reduce learner burden, moving from reactive to a strategic and integrated approach to learning.
Position Responsibilities Oversee efforts to develop and deliver educational and training materials in concert with BMS learning with an intended primary audience of clinical physicians and clinical scientists.
Ensure alignment and compliance with Training Management procedural document(s) Establish a holistic approach to clinical compliance and inspection-readiness by leveraging a framework for Training and Onboarding suitable across the clinical Therapeutic Areas.
Drive GCP training and compliance for the drug development clinical roles and functions within BMS, including the OneClinical RBCs:
Ongoing management of the drug development (both early Early and Late) RBC content Ongoing evaluation of new / updated RBC content based on QMS procedural document updates and roll-out.
Evaluate gaps and develop solutions re:
RBC for all clinical roles (e.
g.
, TAH, CDH, etc.
) beyond current OneClinical RBC Create and lead a Clinical drug development RBC Governance team Evaluate learners' up-to-date status and provide metrics of learner compliance Develop innovative solutions for GCP Training implementation and management Training Strategy:
TA-specific, Department, Process-specific, Competency (On the Job Training, Case Studies, Manager Observation), Soft Skills Attend GxP Training Council Interface with key stakeholders across other departments, as applicable, to support a culture focused on quality across the Enterprise Drive GCP compliance towards inspection readiness at all times Work with R&D Transformational Change and Learning to ensure that the delivery methods and timing of training are adapted to the needs of the business in terms of time allocation, urgency, and criticality.
OneLMS effort - partner with R&D Learning and participate in alignment of SuccessFactors and legacy LMS as well as retirement of identified content and/or migration to BMS system Clinical Onboarding Develop, implement, and manage all aspects of onboarding process for OneClinical and CCoE roles/employees and contingent workers, as applicable Evaluate training innovation opportunities and support their implementation within BMS, as appropriate, in scalable fashion Serve as GCP Training subject matter expert to support quality and compliance efforts across the therapeutic areas and guide compliance to GCP Represent Clinical during inspections and audits, and with responses and CAPA resolution pertaining to GCP Training and RBC Actively engage with Clinical leadership to continually assess areas of training/learning need and/or interest (both therapeutic area specific and across the Enterprise) Navigate Clinical leadership as well as line managers and learners through ambiguity towards clear and actionable decisions regarding training and learning Determine root cause and corrective actions for platforms and systems that affect Clinical training, processes, and efficiencies.
Degree Requirements Bachelor's Degree (or equivalent degree) required.
Degree in a life science, natural science or business preferred.
Experience Requirements 10+years of Industry experience with 8
years of experience in a GxP regulated discipline required.
Demonstrable first-hand experience in developing, implementing, and managing education, training, onboarding strategies and programs.
Thorough knowledge of GCP requirements and global drug development process.
Advanced knowledge of GCP/ICH.
Ability to operate in a complex matrix organization.
Experience and demonstrated proficiency in managing direct/indirect employees and leading teams.
Key Competency Requirements Demonstrates strong leadership presence Reinforces curiosity and challenges the status quo in order to encourage innovative approaches and ideas Proven ability to self-supervise and act independently to identify/resolve issues Leverages connections with internal and external stakeholders Strong Project Management and Stakeholder Management skills Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of quality issues and audit findings Recognized internally and externally as an expert regarding all aspects of GCP Training and Learning Track record of commitment to Quality in all areas Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities Exhibits confidence and professional diplomacy, while effectively relating to people at all levels (internally and externally) Drives culture built on trust, transparency, and execution.
Establishes a learning org culture to facilitate growth and development of our team, processes, and people.
Actively mentors others in the department Advanced oral and written communication skills Able to present to large groups, facilitate interactive discussions, and lead discussions with internal stakeholders High proficiency in, and demonstration of, critical thinking, problem solving, and decision making Anticipates needs, assesses, and manages business and organizational risks Leads on identified process improvement initiatives, as required Proven ability to promote a culture of multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality, and effective communication Travel Required Domestic and International travel may be required.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Adaptability Auditing Biology Business Requirements Clinical Quality Management Clinical Research Estimated Salary: $20 to $28 per hour based on qualifications.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
Functional Area Description The Director, Clinical Process Excellence and Learning Strategy reports to the Senior Director of the Clinical Center of Excellence.
The Clinical Center of Excellence department serves all of Clinical Research and Development across all Therapeutic Areas with the objective to enhance clinical capabilities within the OneClinical organization and optimize ways of operating with a focus on Innovation, Consistency and Quality across the enterprise.
The CCoE serves as the operating bridge between the multiple Therapeutic Areas striving to build a culture of excellence.
The Director, Clinical Process Excellence and Learning Strategy drives all aspects of training and identified areas of learnings as well as onboarding for the OneClinical organization by interfacing and providing guidance to clinical leadership, and clinical teams as appropriate.
This role serves as the primary contact and advisor for all aspects of training, learning, and compliance within the Clinical Development organization.
This role works closely with cross-functional partners, as applicable, to ensure continuous improvement of processes and highest quality standards.
The Director, Clinical Process Excellence and Learning Strategy is accountable to drive process optimization and improvement following standard methodology, ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the Good Clinical Practices document hierarchy.
Position Summary / Objectives The Director, Clinical Process Excellence and Learning Strategy supports and enables OneClinical compliance objectives through the development of the technical training profiles and requirements, based on the activities identified through the clinical Quality Management System (QMS), audit and inspection outcomes, to assure the processes are built/adapted as needed in support of quality by design principles.
This role is accountable for the development, implementation, maintenance, and continuous improvement of role-based curricula (RBC) and certification of study team members across the Research and Development organizations to ensure compliance to GCP requirements in the conduct of clinical trials end to end.
The Director, Clinical Process Excellence and Learning Strategy will be responsible for aligning with key clinical leadership stakeholders including Clinical Therapeutic Heads, Clinical Development Heads and Clinical Science Heads across all Therapeutic Areas in drug development to align training roles with business needs and goals, as well as build capacity to upskill current workforce and train new employees quickly and effectively.
The Director, Clinical Process Excellence and Learning Strategy will lead the development and delivery of educational and training programs focused on advancing clinical development capabilities while developing a high functioning community of practitioners as well as lead initiatives focused on enhancing clinical development innovation and efficiency.
Additionally, this role will continuously evaluate opportunities to make learning user friendly and reduce learner burden, moving from reactive to a strategic and integrated approach to learning.
Position Responsibilities Oversee efforts to develop and deliver educational and training materials in concert with BMS learning with an intended primary audience of clinical physicians and clinical scientists.
Ensure alignment and compliance with Training Management procedural document(s) Establish a holistic approach to clinical compliance and inspection-readiness by leveraging a framework for Training and Onboarding suitable across the clinical Therapeutic Areas.
Drive GCP training and compliance for the drug development clinical roles and functions within BMS, including the OneClinical RBCs:
Ongoing management of the drug development (both early Early and Late) RBC content Ongoing evaluation of new / updated RBC content based on QMS procedural document updates and roll-out.
Evaluate gaps and develop solutions re:
RBC for all clinical roles (e.
g.
, TAH, CDH, etc.
) beyond current OneClinical RBC Create and lead a Clinical drug development RBC Governance team Evaluate learners' up-to-date status and provide metrics of learner compliance Develop innovative solutions for GCP Training implementation and management Training Strategy:
TA-specific, Department, Process-specific, Competency (On the Job Training, Case Studies, Manager Observation), Soft Skills Attend GxP Training Council Interface with key stakeholders across other departments, as applicable, to support a culture focused on quality across the Enterprise Drive GCP compliance towards inspection readiness at all times Work with R&D Transformational Change and Learning to ensure that the delivery methods and timing of training are adapted to the needs of the business in terms of time allocation, urgency, and criticality.
OneLMS effort - partner with R&D Learning and participate in alignment of SuccessFactors and legacy LMS as well as retirement of identified content and/or migration to BMS system Clinical Onboarding Develop, implement, and manage all aspects of onboarding process for OneClinical and CCoE roles/employees and contingent workers, as applicable Evaluate training innovation opportunities and support their implementation within BMS, as appropriate, in scalable fashion Serve as GCP Training subject matter expert to support quality and compliance efforts across the therapeutic areas and guide compliance to GCP Represent Clinical during inspections and audits, and with responses and CAPA resolution pertaining to GCP Training and RBC Actively engage with Clinical leadership to continually assess areas of training/learning need and/or interest (both therapeutic area specific and across the Enterprise) Navigate Clinical leadership as well as line managers and learners through ambiguity towards clear and actionable decisions regarding training and learning Determine root cause and corrective actions for platforms and systems that affect Clinical training, processes, and efficiencies.
Degree Requirements Bachelor's Degree (or equivalent degree) required.
Degree in a life science, natural science or business preferred.
Experience Requirements 10+years of Industry experience with 8
years of experience in a GxP regulated discipline required.
Demonstrable first-hand experience in developing, implementing, and managing education, training, onboarding strategies and programs.
Thorough knowledge of GCP requirements and global drug development process.
Advanced knowledge of GCP/ICH.
Ability to operate in a complex matrix organization.
Experience and demonstrated proficiency in managing direct/indirect employees and leading teams.
Key Competency Requirements Demonstrates strong leadership presence Reinforces curiosity and challenges the status quo in order to encourage innovative approaches and ideas Proven ability to self-supervise and act independently to identify/resolve issues Leverages connections with internal and external stakeholders Strong Project Management and Stakeholder Management skills Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of quality issues and audit findings Recognized internally and externally as an expert regarding all aspects of GCP Training and Learning Track record of commitment to Quality in all areas Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities Exhibits confidence and professional diplomacy, while effectively relating to people at all levels (internally and externally) Drives culture built on trust, transparency, and execution.
Establishes a learning org culture to facilitate growth and development of our team, processes, and people.
Actively mentors others in the department Advanced oral and written communication skills Able to present to large groups, facilitate interactive discussions, and lead discussions with internal stakeholders High proficiency in, and demonstration of, critical thinking, problem solving, and decision making Anticipates needs, assesses, and manages business and organizational risks Leads on identified process improvement initiatives, as required Proven ability to promote a culture of multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality, and effective communication Travel Required Domestic and International travel may be required.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Adaptability Auditing Biology Business Requirements Clinical Quality Management Clinical Research Estimated Salary: $20 to $28 per hour based on qualifications.
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