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. 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 Protocol Management Office (PMO) at Clinical Center of Excellence (CCoE) ensures scientific rigor and quality of clinical documents within Drug Development (DD). A critical component of the CCoE responsibilities is the oversight of the TA-aligned Protocol Review Committee (PRC) within DD. As an integral member of the PRC team, the PRC Lead helps achieve these objectives through leading the Therapeutic Area (TA) PRC process and supporting clinical teams through the process steps. The PRC Lead will drive implementation of the PRC process, work collaboratively with key stakeholders to strive for the highest quality output and audit compliance documentation.
In addition, the PRC Lead role will work with peers to standardize the process. PRC Lead must have an innovative mindset, leveraging technology to continuously improve the PRC workflow. The Lead will also serve as a process expert supporting the Quality and the Governance process initiatives to help drive improvement activities aligned with the QMS programs. The PRC Lead role will also partner with Enterprise Operational Excellence to assist in driving execution of the Governance Model as well as support their continuous improvement efforts. The role will also be supporting other key enterprise projects as appropriate.
Key Responsibilities:
Serve as process Lead for multiple TA specific PRC(s)
Lead PRC process and work closely with PRC Chairs to drive the PRC meetings
Ensure quality, scientific rigor and feasible to of planned studies in alignment with the endorsed strategy from strategic review and endorsement
Facilitate cross functional clinical and scientific leadership review and endorsement of all new clinical study protocols and protocol amendments
Oversee the Document Review process for Essential Protocol Elements & Revised EPEs, Statistical Analysis Plans (SAP) & Revised SAPs, Data Monitoring Committee (DMC) Charters & Revised DMC Charters, Independent Event Adjudication Charters, Study Steering Committee Charters (at the discretion of the TA Head), Asset Program Elements
Guide each study team through PRC review to ensure document quality, through assessing team readiness, triaging appropriate review, clear documentation of decisions/approvals and process efficiency
Lead projects to ensure continuous improvement of the PRC process
Leverage technology and partner with IT, develop, refine and report outcome-based metrics for the PRCs
Determine root cause and corrective actions for platforms and systems that affect PRC process and efficiencies, lead improvement efforts
Help develop norms and standards, including best practices in meeting management and guidance for participants in processes, to be shared across DD
Design comprehensive training programs and materials tailored to PRC member roles and responsibilities
Deliver formal group training sessions and hold open office hours to provide direct support to our teams, answer questions, and reinforce protocol knowledge and best practices
Use appropriate change management and communication principles
Manage initiatives related to Quality and the Governance process
Partner with QMS and governance to align with overall quality process strategy and execution with inspection ready mindset
Represent PRC during inspections and audits, and support management of responses and CAPA resolution for clinical development related findings
Contribute to CCoE and cross functional continuous improvement initiatives
Provide regular and timely updates to manager
Oversee a systematic process for receiving, logging, tracking, and storing all documents routed to the PRC. Utilize digital document management tools to monitor the status of documents, ensure traceability, and guarantee files are securely archived for regulatory compliance and future reference
Monitor and manage PRC performance metrics and operations, including review turnaround times, workload distribution, and compliance issues
Supporting Clinical Protocol process, providing metrics such as primary drivers of protocol amendments, timing of the amendments
Lead quarterly PRC Community of Practice meetings with TA Chairs and cross-functional stakeholders.
Education & Experience:
Bachelor’s degree in life sciences, healthcare, or a related discipline (advanced degree preferred)
Min 5+ years of biopharma industry experience
Experience in regulatory/protocol review processes within clinical research
Excellent organizational and project management skills
Effective communicator across study leadership and clinical functions
Proficiency with document management systems and eTMF
Commitment to process improvement and operational excellence
Strong ability to develop and deliver training materials
Cross-functional team leadership experience
Familiarity with SOP management and network-wide communications
Proficiency in Excel and PowerPoint, open to technological advancements
Curious, proactive, and eager to improve ways of working
Ability to provide strategic recommendations
Experienced in fast-paced, matrixed, and global trial environments
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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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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 a supportive culture, promoting global participation 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 an 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.
Supporting People with Disabilities
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/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1600074 : Associate Director, Protocol Review Committee (PRC) Lead