Bristol-Myers Squibb Company

Clinical Operations Portfolio Lead

Princeton, NJ, US
Apr 12, 2018
Required Education
Masters Degree/MBA
Position Type
Full time
The Clinical Operations Portfolio Lead is accountable for managing the global clinical operational book of work executed by PRA on behalf of Innovative Medicines Development. This individual is a player-coach, providing support and oversight to Clinical Operations Leads who are overseeing individual assets or programs. This individual may also take on asset or program work if necessary. The scope of clinical trial work is through all phases of development and through to regulatory approval.

Primary Responsibilities:
  • Oversee a high-performing team of Clinical Operations Leads who help to deliver timely milestones and deliverables, without sacrificing quality
  • Oversee the Clinical Operations book of work, and ensure that BMS staffing plans are in place to support those activities, consistent with the outsourced model in place for the legacy CFI portfolio
  • Work with Development Teams and CRO partners to drive and accelerate the execution of clinical studies
  • Help build a high-performing externally-sourced team using an array of tools to enhance team effectiveness and to foster partnerships across multifunctional external stakeholders
  • Support Innovative Medicines Development leadership team in facilitation of strategic development options and in design and execution of initiatives to advance the overall organization
  • Provide timely and insightful updates to clinical trial progress to support effective and efficient decision making and trade-offs
  • Monitors operational progress and swiftly addresses and manages obstacles Design, review and execute operational plans (monitoring, recruitment, geographic deployment, data review) through innovative external partner relationships
  • Contributes to the development of industry-leading approaches in clinical operations through adoption of innovative processes and technologies that deliver high quality, timely clinical trial data
  • Provides operational insight and leadership into Business Development diligence and post-transaction integration activities
  • Supports externally-facing, pipeline-enabling initiatives such as partnerships with advocacy groups and site networks

Experiences/Knowledge Desired:
  • An advanced degree preferred i.e.; Master's degree, PhD, Pharm.D, with at least 10 years of clinical operations industry, biotech or CRO experience
  • In-depth knowledge of the drug development process and overall planning, project management and clinical operations of a clinical development program.
  • Recognized skill in managing drug R&D programs across all phases of development, across multiple therapeutic areas, and across major geographies
  • Significant experience and skillset managing outsourced studies in partnership with CROs, SMOs, and local site networks. Ability to define and build non-traditional outsourcing partnerships
  • Experience in conducting global clinical trial programs across major worldwide markets, including insight into Japan and China development strategies
  • Awareness of different types of data generation and how they can contribute to overall data packages (ISRs, Cooperative group studies, non-interventional research, expanded access protocols, etc.)
  • Demonstrated ability to collaborate and build strong relationships with Senior Leaders within and outside of R&D, Worldwide Commercial, Global Regulatory, Exploratory Development and Medical.
  • Ability to leverage business acumen, industry knowledge, organization insights and IT-Planning/Reporting system expertise to make significant contribution to the development and execution of the overall business strategy
  • Highly inquisitive, externally focused, divergent thinker with the ability to simplify amidst complexity. Proven ability to influence thinking, resolve dynamic tensions, drive and manage change, achieve measurable results
  • Comfortable working in a fast-paced environment where speed is paramount. Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets.
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions

This position is based in Lawrenceville, New Jersey