Associate Director, Protocol Review Committee (PRC) Lead (R1561045-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Clinical Development Center of Excellence (CoE) ensures scientific rigor and quality of clinical documents within Global Drug Development (GDD). A critical component of the CoE responsibilities is the oversight of the TA-aligned PRCs within GDD. As an integral member of the PRC team, the PRC Lead helps achieve these objectives through by managing the Therapeutic Area (TA) PRC Process and supporting clinical teams through the process steps. The PRC Lead will help 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 and continuously improve the PRC workflow as appropriate. The role will serve as a process expert supporting the Fusion/ Quality Management Systems 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.
Process owner for 1-2 TA specific PRC(s)
Facilitate each Asset Teams journey through PRC review to ensure team readiness, appropriate review, clear documentation of decisions/approvals and process efficiency
Manage projects related to the ongoing implementation and continuous improvement of the PRC process
In coordination with the CoE Head and partnering with BI&A, develop, refine and report outcome-based metrics for the PRCs
Manage other initiatives related to Quality and the Governance process
Help develop norms and standards, including best practices in meeting management and guidance for participants in processes, to be shared across GDD
Partner with QMS and governance to align with overall quality process strategy and execution
Use appropriate change management and communication principles
Desired Background, Knowledge and Experience
Advanced degree (MA, MS, MBA, PhD, etc.) and 5+ years of biopharma industry experience
Strong project management experience in the biopharma industry; PMP certification is desirable
Strong oral and written communications skills, as well as strong analytical ability
Demonstrated ability to build relationships, influence, negotiate and drive organizational engagement
Ability to handle multiple concurrent projects in a dynamic and challenging environment
Flexibility to adapt to changing needs of the organization
Understanding of relevant opportunities, interdependencies and complex trade-offs
Ability to manage multiple stakeholders, competing priorities and navigate uncertainty across the matrix
Experience in process management, continuous improvement and leading matrix leadership teams a plus
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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