Director, Program Operations Leader, Early Clinical Trial Development

2 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time
This position is a hybrid role requiring a minimum of 3 days on-site in Basking Ridge, NJ or Armonk, NY, with no option for remote work. The Program Operations Leader (POL) will oversee and implement the operational strategy for the delivery of one or more complex programs in Clinical Trial Management (CTM). This role involves making vital decisions related to quality, timelines, and budgets for clinical research studies, ensuring compliance with regulations, ICH/GCP guidelines, and company Standard Operating Procedures (SOPs) within the assigned program(s). As a member of the Clinical Trial Management extended leadership team, the POL engages with senior management, external vendors, collaboration partners, and clinical study personnel to drive project and department initiatives. The POL is also accountable for managing clinical trial management staff and plays a crucial role in shaping the functional strategy of Clinical Trial Management. The Director POL is expected to work autonomously and with a high degree of independence. In your day-to-day responsibilities, you will:
  • Oversee the success of the clinical study team(s) within the program(s)
  • Communicate program status, risks, and changes that could impact quality, timelines, and/or budget
  • Provide operational insights during clinical program/study development
  • Coordinate clinical study timelines
  • Contribute to Clinical Study Concepts (CSC)
  • Develop and execute operational strategy, overseeing early study planning budget and timelines
  • Provide clinical operations expertise during protocol design, feasibility, study start-up, and conduct phases
  • Manage clinical study budgets within the program
This position may suit you if you possess:
  • Strong interpersonal and leadership skills
  • Ability to offer operational strategic direction for clinical programs
  • Proficiency in solving complex issues using technical expertise
  • Awareness of industry trends
  • Analytical skills and data-driven problem-solving approach
  • Effective verbal, written, and presentation skills
  • Proactive and disciplined work ethic with strong time management and prioritization
  • Negotiation skills and ability to influence senior partners
  • Budget management experience and financial acumen
  • Track record of team building, leadership, and collaboration
  • Expertise in project management, cross-functional engagement, and organizational skills
To be eligible for this role, you must hold a Bachelor's degree and have a minimum of 12 years of relevant experience in the pharmaceutical industry, with 8 years specifically in Clinical Trial Management. Experience in early-phase clinical trials is highly desirable.

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