Director, Biospecimen Management Cell Therapy & Early Oncology - Bristol Myers Squibb
Princeton, NJ
About the Job
Working with Us
Challenging. 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 .
Position Summary:
The Director of Biospecimen Management for Cell Therapy & Early Oncology will efficiently and independently perform the duties and responsibilities outlined below.
Reports to the Senior Director, Biospecimen & Imaging Management HOCT.
Duties/Responsibilities:
+ Lead the Biospecimen Management Team supporting CT and Early Oncology studies, including goal setting, deliverables, performance management reviews, and coaching.
+ Oversee and provide guidance on the development of comprehensive program and protocol-level biospecimen management plans for all studies.
+ Ensure the timely and efficient delivery of all biospecimen operational aspects of clinical studies across all stages (start-up, conduct, and close-out) with appropriate quality oversight and standards.
+ Escalate issues to appropriate functional areas when there are deviations from established standards or recommended guidelines.
+ Maintain knowledge of existing and new regulatory guidance related to biospecimen management.
+ Enhance IT capabilities to improve operational effectiveness, biospecimen tracking, and performance metrics capture.
+ Seek opportunities to enhance the value of external vendor relationships (e.g., Central Laboratory, 3rd party specialty labs) through early strategic engagement and ongoing partnership.
+ Engage and partner with all GDO functions , other R&D functions, and key internal and external stakeholders to improve organizational knowledge and maturity on risk and issue management in the biospecimen space.
+ Develop and update policies, standard operating procedures (SOPs), and working procedures (WPs) related to biospecimen planning and utilization.
+ Maintain awareness of market trends and industry best practices and incorporate findings into day-to-day operations, including involvement in key external organizations (e.g., SCOPE, SLAS, ISBER) related to biospecimen management.
+ Ensure compliance in biospecimen management areas, partnering with site-facing roles to address timeliness of query resolution and specimen compliance.
+ Collaborate with data management to ensure oversight of database lock delivery.
+ Support outsourcing management in efficient and effective governance meetings, serving as a key member and advisor to operational and strategic management committees and additional project meetings and escalations as necessary.
+ Develop and retain a diverse workforce while ensuring adequate work-life balance.
+ Assign and maintain the Book of Work for the organization, ensuring proper and timely functional support of trials.
+ Develop and maintain organizational metrics.
+ Serve as the integration/collaboration lead for other strategic and process improvement initiatives across internal and external organizations.
+ Coordinate feedback on imaging management-related findings for all internal and external site audits, follow up on corrective and preventative actions to completion and implementation, and serve as a functional expert on internal audits and vendor visits.
+ Handle personnel hiring, training, performance, compliance, and development for the Biospecimen Management team.
+ Provide side-by-side coaching, deliver performance evaluations, and set goals for the team. Mentor and maintain motivation levels in a dynamic environment.
+ Support study deliverables and transition coverage in addition to managing the team.
Qualifications:
Specific Knowledge, Skills, Abilities:
+ Deep knowledge and expertise of the biospecimen life-cycle, especially within biomarker discovery and development, is required.
+ Ability to provide clear, unambiguous expectations and priorities for the team and manage effectively in an environment of change, speed, and complexity.
+ Ability to operate in a complex matrix organization, lead through influence with excellent communication and negotiation skills, and resolve conflict constructively while maintaining a customer-focused mindset.
+ Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, act with a sense of urgency, accountability, and integrity, and have fun along the way.
+ Proven track record in successfully managing, leading, and growing a team responsible for working within a large cross-functional matrixed environment, with at least 2-4 years of managerial experience.
+ Serve as a point of escalation to provide guidance to the team and/or directly resolve issues with partners and stakeholders.
+ Ensure biospecimen collection strategies and documentation are compliant with ICH and GCP guidance.
+ Serve as a subject matter expert during audits and inspections, as required.
Education/Experience/ Licenses/Certifications:
+ Bachelor's Degree in a relevant discipline.
+ Master's Degree preferred.
+ Minimum 7 years of global experience in clinical drug development, biospecimen management, or related experience.
+ Minimum 2-4 years of leadership experience managing global teams.
Travel:
+ 5-10% domestic.
The starting compensation for this job in Seattle, WA is a range from $194,000 - $242,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 Careers
With a single vision as inspiring as Transforming patients' lives through science™ , 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 Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1584025
Updated: 2024-09-23 06:52:21.593 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. 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 .
Position Summary:
The Director of Biospecimen Management for Cell Therapy & Early Oncology will efficiently and independently perform the duties and responsibilities outlined below.
Reports to the Senior Director, Biospecimen & Imaging Management HOCT.
Duties/Responsibilities:
+ Lead the Biospecimen Management Team supporting CT and Early Oncology studies, including goal setting, deliverables, performance management reviews, and coaching.
+ Oversee and provide guidance on the development of comprehensive program and protocol-level biospecimen management plans for all studies.
+ Ensure the timely and efficient delivery of all biospecimen operational aspects of clinical studies across all stages (start-up, conduct, and close-out) with appropriate quality oversight and standards.
+ Escalate issues to appropriate functional areas when there are deviations from established standards or recommended guidelines.
+ Maintain knowledge of existing and new regulatory guidance related to biospecimen management.
+ Enhance IT capabilities to improve operational effectiveness, biospecimen tracking, and performance metrics capture.
+ Seek opportunities to enhance the value of external vendor relationships (e.g., Central Laboratory, 3rd party specialty labs) through early strategic engagement and ongoing partnership.
+ Engage and partner with all GDO functions , other R&D functions, and key internal and external stakeholders to improve organizational knowledge and maturity on risk and issue management in the biospecimen space.
+ Develop and update policies, standard operating procedures (SOPs), and working procedures (WPs) related to biospecimen planning and utilization.
+ Maintain awareness of market trends and industry best practices and incorporate findings into day-to-day operations, including involvement in key external organizations (e.g., SCOPE, SLAS, ISBER) related to biospecimen management.
+ Ensure compliance in biospecimen management areas, partnering with site-facing roles to address timeliness of query resolution and specimen compliance.
+ Collaborate with data management to ensure oversight of database lock delivery.
+ Support outsourcing management in efficient and effective governance meetings, serving as a key member and advisor to operational and strategic management committees and additional project meetings and escalations as necessary.
+ Develop and retain a diverse workforce while ensuring adequate work-life balance.
+ Assign and maintain the Book of Work for the organization, ensuring proper and timely functional support of trials.
+ Develop and maintain organizational metrics.
+ Serve as the integration/collaboration lead for other strategic and process improvement initiatives across internal and external organizations.
+ Coordinate feedback on imaging management-related findings for all internal and external site audits, follow up on corrective and preventative actions to completion and implementation, and serve as a functional expert on internal audits and vendor visits.
+ Handle personnel hiring, training, performance, compliance, and development for the Biospecimen Management team.
+ Provide side-by-side coaching, deliver performance evaluations, and set goals for the team. Mentor and maintain motivation levels in a dynamic environment.
+ Support study deliverables and transition coverage in addition to managing the team.
Qualifications:
Specific Knowledge, Skills, Abilities:
+ Deep knowledge and expertise of the biospecimen life-cycle, especially within biomarker discovery and development, is required.
+ Ability to provide clear, unambiguous expectations and priorities for the team and manage effectively in an environment of change, speed, and complexity.
+ Ability to operate in a complex matrix organization, lead through influence with excellent communication and negotiation skills, and resolve conflict constructively while maintaining a customer-focused mindset.
+ Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, act with a sense of urgency, accountability, and integrity, and have fun along the way.
+ Proven track record in successfully managing, leading, and growing a team responsible for working within a large cross-functional matrixed environment, with at least 2-4 years of managerial experience.
+ Serve as a point of escalation to provide guidance to the team and/or directly resolve issues with partners and stakeholders.
+ Ensure biospecimen collection strategies and documentation are compliant with ICH and GCP guidance.
+ Serve as a subject matter expert during audits and inspections, as required.
Education/Experience/ Licenses/Certifications:
+ Bachelor's Degree in a relevant discipline.
+ Master's Degree preferred.
+ Minimum 7 years of global experience in clinical drug development, biospecimen management, or related experience.
+ Minimum 2-4 years of leadership experience managing global teams.
Travel:
+ 5-10% domestic.
The starting compensation for this job in Seattle, WA is a range from $194,000 - $242,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 Careers
With a single vision as inspiring as Transforming patients' lives through science™ , 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 Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1584025
Updated: 2024-09-23 06:52:21.593 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
