Bristol-Myers Squibb Company

Compliance Lead, Oncology Clinical Development

Princeton, NJ, US
Dec 07, 2018
Required Education
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

** The Grade/Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate **

  • The Clinical Compliance Lead is essential to the sustainability and success of the R&D Pipeline
  • The role reports into an Oncology Program Lead and is a key member of the R&D Quality Leadership Team
  • Specifically, the Compliance Lead in Clinical Development is responsible for:
    • Providing strategic and clinical leadership of the global clinical compliance and continuous improvement functions within Oncology Clinical Development (OCD) and Innovative Medicines Development (IMD)
    • Ensuring communication of R&D Quality workstreams and bidirectional feedback across OCD (Early/Late) and IMD to assure staff understand and apply GCP, ICH quality guidelines, and federal regulations
    • Providing clinical input to ensure appropriate vendor oversight in outsourced clinical trials and partnering with BMS Quality function as the Clinical contact for any global health authority inspections - site or sponsor related activities
    • Developing and implementing a culture of continuous improvement, ensuring that comprehensive corrective action preventative action plans (CAPA) are developed, root cause analysis is captured, trended and adaptations to process to support of a quality mindset to each audit or health authority inspection
    • Identifying, building and maintaining clinical training programs for staff in Clinical Development. This includes on boarding and core curriculum requirements, by role in accordance with Standard Operating Procedures (SOPs) globally
    • Leveraging core risks and root causes identifying needs, directing development and continuous improvement of processes, systems and global strategies to support evolution of OCD and IMD business operating models with a particular focus on Good Clinical Practices (GCP)
    • Assuring quality by design across the BMS R&D portfolio of clinical trials globally to enable the organization to be inspection and audit ready at all times
    • Supporting the development of the Risk Assessment and Categorization Tool in support of Risk Based Monitoring (RBM)
    • Ensuring streamlined processes, productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products
    • Representing the Company in key interactions with key external partners as part of any compliance committee or industry group
    • Serving as a leader across R&D, and developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management
    • Ensuring Clinical representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative)
    • Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities
    • Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that fosters accountability
  • Work consistently in a matrix environment
  • MD, PhD, Pharm D or other health related scientific field with a deep understanding of clinical drug development and GCP
  • The position is based in the Princeton, NJ area

  • Working in a cross-functional matrix team
  • Clinical development activities from site(s) initiation to study discontinuation
  • Activities around study implementation and knowledge of GCP and regulatory requirements
  • In collaboration with GRS and GPV&E, have designed and implemented safety monitoring plans
  • Interpretation of clinical data and making appropriate decisions and recommendations
  • Addressing relevant clinical queries; contributing to responses related to HA and IRB questions

eam members and governance bodies to enhance the R&D Quality strategy
    • Addresses relevant clinical queries; and authors responses to CAPAs and HA and IRB questions

  • Identify and build relationships
  • Acts as the Clinical expert to the R&D Quality Team
  • Ability to work and communicate efficiently
  • Identify and builds relationships with principal investigators and key internal stakeholders
  • Maintain a strong medical/scientific reputation within R&D Quality
  • Contribute to Health Authority interactions and inspections across Clinical Development
  • Share specific clinical strategies with OCD and IMD
  • Study-specific clinical design and execution with a focus on GCP
  • Manage communication with key stakeholders (senior)

  • Understanding of the fundamentals of clinical development and GCP (e.g. from working as an investigator, working in an adjacent group in industry - e.g. monitoring)
  • Limited clinical research experience (substantial academic research experience could potentially substitute)

  • Relevant clinical research experience (relevant academic research experience could potentially substitute)
  • Has a deep understanding of the fundamentals of protocol development and GCP, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock
  • Has a history of handling multiple, complex, studies in parallel
  • Has a history of prior meaningful participation in regulatory submissions
  • Has a history of strong interaction with thought leaders
  • Proven team leadership capability
  • Performs as an individual contributor
  • Identifies when an issue is present and begins to address