Sr. Director, Clinical Program Management

Bristol Myers SquibbSan Diego, CA
31d

About The Position

The Sr. Director, Clinical Program Management, reporting to the Head of Clinical Operations, is accountable of on-time and on-budget delivery of assigned clinical study(ies) within the RayzeBio portfolio at the highest quality standards. The role will oversee all operational aspects of the global clinical program according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state or regional regulations, in order to achieve established corporate goals within timelines and budget.

Requirements

  • BA/BS degree, scientific or healthcare discipline preferred
  • Minimum 12 years relevant clinical operations experience in pharmaceutical/biotech industry, with at least 7 years in oncology trials
  • Independent professional who proactively communicates frequently and effectively.
  • Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making
  • Detail and action-oriented, organized and committed to quality and consistency.
  • Ability to work in a dynamic environment with a high degree of flexibility.

Nice To Haves

  • Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable
  • Expertise in Microsoft Project and Smartsheets desired.

Responsibilities

  • Develop and lead the clinical operational strategy for complex, global programs, setting direction for clinical study teams, CROs, and vendors to ensure study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines.
  • Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting.
  • Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level.
  • Contribute to and provide input on clinical development plans, protocol design, and overall program strategy.
  • Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals.
  • Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership.
  • Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership.
  • Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness.
  • Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed.
  • Champion process improvement initiatives to optimize operational effectiveness across programs.
  • Perform additional related duties as assigned.
  • Up to 20% travel required.

Benefits

  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume

What This Job Offers

Job Type

Full-time

Career Level

Director

Industry

Chemical Manufacturing

Number of Employees

5,001-10,000 employees

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service