Associate Director, Clinical Data Standards Lead

5 days ago

Berkeley Heights, New Jersey, United States Bristol-Myers Squibb Full time
Job Summary

Bristol-Myers Squibb is seeking an experienced Associate Director, Clinical Data Standards to lead our clinical data standards activities across multiple clinical development programs. As a key member of our team, you will oversee a team of standards professionals, develop and communicate data standards implementation strategy, and contribute to the BMS R&D pipeline.

Key Responsibilities
  • Leadership and Team Management: Provide leadership to a team of standards professionals, overseeing planning, coordination, and timely delivery of global standards elements for study database consumption.
  • Resource Management: Ensure adaptive management of a standards team through effective deployment of resources and streamlined processes, ensuring productivity targets, validity, and quality of the data gathered in support of the evolving portfolio of BMS products.
  • Global Standards Requests: Manage the book of work for global standards requests, assigning resources to standards requests and initiatives, and regularly monitoring workloads to avoid delays in delivery due to resource constraints.
  • Feedback and Coaching: Provide ongoing feedback, coaching, and career development to staff, including engagement and retention support to maximize their potential.
  • Procedural Documents: Ensure procedural documents are reflective of industry standards, easily followed, and regularly maintained.
  • Continuous Improvement: Contribute to the development and application of smart systems and optimal approaches to support the end-to-end clinical trial data lifecycle, from collection through submission.
  • Accountability and Communication: Hold accountability to resolve issues and proactively develop solutions, within the functional and across functions, and actively participate in and/or lead continuous improvement activities.
  • Culture and Diversity: Develop and promote a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.
  • Quality Oversight: Ensure effective quality oversight and management of external partners performing standards activities on behalf of BMS.
  • Stakeholder Engagement: Develop strong and productive working relationships with key stakeholders throughout GDMCM, GCO, Global Biometrics & Data Sciences, and BMS, with the ability to think strategically across a broad portfolio and effectively express views to senior management.
Requirements
  • Education: Bachelor's degree required, with an advanced degree preferred.
  • Experience: At least 12 years of global clinical trial expertise, with a successful track record of leading through influence, working across complex, global organizational matrices, including 3 years of line management experience. Immuno-Oncology therapeutic experience is highly desirable.
  • Skills and Knowledge: Good understanding of the drug development process, with proven expertise in clinical trial execution and data acquisition as well as analysis reporting in a global arena. Strong knowledge of industry clinical data standards and processes, including CDISC: CDASH/SDTM/ADaM, SDSP, and industry best practice documentation from regulatory authorities.
About Us

Bristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to creating an inclusive culture that values diversity of thought, promotes integrity, and fosters accountability. If you are passionate about making a difference in the lives of patients and are looking for a challenging and rewarding career, we encourage you to apply.

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