Regional Clinical Operations Director

2 months ago

Uxbridge, United Kingdom Bristol Myers Squibb Full time

Job Summary

The Director, Regional Delivery Lead is a leadership-level role within the Regional Clinical Operations function and is considered essential to the sustainability and success of the Bristol Myers Squibb R&D pipeline. This role reports to the Executive Director, Head of Regional Delivery Lead and is a key member of the Regional Delivery Lead Leadership team.

Key Responsibilities

  • Drives strategy and operational leadership for Regional Delivery Leads in a specific region to ensure regional accountability of all country clinical operation teams supporting the Bristol Myers Squibb R&D portfolio.
  • Proficient in drug development strategy and delivery; actively coordinates with the Global Trial Management organization to the Regional Clinical Operations Cluster and Country Heads to ensure alignment and accountability for execution by the country clinical operations teams via the team of Regional Delivery Leads within their regional remit.
  • Assumes responsibility of owning a cross-functional relationship within a specific therapeutic area across drug development and worldwide medical.
  • Builts and leads a regional team of Regional Delivery Leads (RDLs) that drive accountability and delivery of all country clinical operations team commitments within a region (e.g., Americas, EMEA, APAC, etc.) for assigned trials throughout the end-to-end study lifecycle by coordinating between global and local teams.
  • Monitors and manages regional delivery of study-start-up (regional input into protocol development, country/site feasibility and site selection), study conduct and study closure.
  • Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff to maximize their potential.
  • Engages with RCO Cluster and Country Heads and other relevant stakeholders to support the synthesis of local trends which would influence successful clinical trial execution.
  • Member of the Regional Delivery Lead Leadership team who will identify influencing factors which require the adaptive management of site monitoring and site management resources.
  • Engages with RCO Leadership to ensure proper escalation of trends which may impact the strategic value of opportunities.
  • Proficient in local market regulatory environment within a region, providing direction, guidance and support during inspection preparation, sponsor, and site activities.
  • Serves as a leader across R&D and develops strong and productive working relationships with key stakeholders throughout Bristol Myers Squibb with the ability to think strategically across a broad portfolio and effectively expresses views to senior management.
  • Ensures RCO representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative).
  • Engages and energizes employees through communication of goals, priorities, and other business critical information as well as focus on employee value proposition, development, and retention activities.
  • Develops and promotes a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

Qualifications & Experience

  • Bachelor's degree required with an advanced degree preferred.
  • Minimum of 10 years of experience in project management in a pharma/biotech/CRO organization.
  • Significant experience in the planning, conduct and management of clinical programs (Phase I-IV) globally or within a region.
  • Demonstrated ability to drive project-related activities.
  • Minimum 5 years of experience in managing teams and a strong track record of motivating, aspiring, coaching, and developing direct reports.
  • Experience in driving a team to deliverables and setting up a strong culture of accountability in achieving set goals.
  • In-depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
  • Understands the drug development process, from early to late stage, including lifecycle management.
  • Deep knowledge of clinical trial operations including monitoring methodologies, systems, regulations/compliance, budget and resource management and site-facing engagements.
  • Knowledge of the external country clinical trial environment and stakeholders therein.

Key Competency Requirements

  • Demonstrated organizational and planning skills and independent decision-making ability.
  • Highly organized and motivated possessing excellent verbal and written communication skills (both English and local language), interpersonal skills and presentation skills to inform and guide others.
  • Passionate, accountable, innovative, and a critical thinker who balances risk/speed for maximum results.

Travel Requirements

  • Up to 30% of travel required.

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