Bristol Myers Squibb Company

Head of the Clinical Center of Excellence

Location
Princeton, NJ, United States
Posted
Aug 28, 2020
Ref
R1528002
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Lead the BMS Protocol Review Committee

Develop and lead a Protocol Management Office (PMO) responsible for the review of protocols, statistical analysis plans (SAPs), data monitoring committee (DMC) charters, and other key documents/plans across the BMS portfolio to ensure outputs of the highest scientific quality.
  • Provide rigorous scientific review/comment/revision to pivotal protocols/documents across all BMS therapeutic areas (TAs) to ensure they meet appropriate levels of scientific quality.
  • Manage a group of individuals that coordinates review activities across all BMS TAs. Ensures resources are commensurate with requisite activities.
  • Liaise with senior stakeholders (e.g., TA heads within Global Development) in furthering the scientific quality of outputs and addressing issues that arise in the course of PRC review. Provide guidance to the matrix team of PRC leaders within the TAs to drive consistent review and processes.
  • Ensure review process leads to high quality, scientifically rigorous, and feasible studies and meets regulatory / compliance standards.
  • Develop and refine process to handle protocol/document submission as well as associated triage criteria.
  • Integrate protocol and document review process into overarching governance processes.
  • Create, implement, and maintain an integrated, organized compliant system for storing and retrieving PRC materials, meeting output, and decisions taken.
  • Develop metrics and collect indicators that enable ability to track output and trends associated with protocol development and can be applied to identify areas of continuous improvement.
  • Incorporate state-of-the-art advances as relates to protocol development/study design and associated review based on internal and external insights from industry, regulators, and other bodies.


Lead the development and delivery of educational and training programs focused on advancing clinical development capabilities while developing a high functioning community of practitioners
  • Oversee efforts to develop and deliver educational and training materials in concert w/ BMS learning with an intended audience of clinical physicians and scientists.
  • Support development of best practices hub focused on enhancing clinical development innovation, execution, and delivery.
  • Nurture a community of practitioners that optimizes collaboration through internal knowledge sharing to enhance the organization's clinical development skills and capabilities.


Lead initiatives focused on enhancing clinical development innovation and efficiency, lead a group focused on developing and maintaining clinical processes, and serve as senior voice in supporting quality and compliance-related activities across development

  • Oversee group focused on developing, enhancing, maintaining, and measuring effectiveness / compliance of clinical processes.
  • Incorporate outputs from initiatives across the enterprise into the development process (e.g., digital innovation, real-world capabilities, and patient advocacy).
  • Evaluate industry leading capabilities and support their implementation within BMS, as appropriate, in scalable fashion in support of clinical deliverables
  • Serve as clinical development subject matter expert to support quality and compliance efforts across the therapeutic areas and guide compliance to GCP. Interface with key stakeholders across other departments to support a culture focused on quality across the Enterprise.


Requirements
  • Degree in Life Sciences (MD, PhD, PharmD, MS, RN or other scientific field preferred) with extensive experience in clinical development and the design and execution of clinical studies.
  • Deep knowledge of regulatory and compliance requirements, clinical operations, statistics and epidemiology.
  • Deep understanding of early through late stage drug development issues and challenges, as well as extensive experience with protocol development and review
  • Excellent problem solving capabilities with ability to understand and simplify processes and interfaces between complex organizations.
  • Successful track record of leading through influence and working across complex, global organizational matrices


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.