Associate Director, Protocol Review Committee (PRC) Lead

Bristol Myers Squibb • Princeton, NJ

9d • Hybrid

About The Position

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.

Requirements

• 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

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.

Benefits

• 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: T he 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level