Clinical Operations Manager

1 day ago

Gaithersburg, United States GForce Life Sciences Full time

Duration: 12 months, contract-to-hire based on business needs and performance


Position Overview:

The Global Clinical Operations Program Director (GPD) plays a critical role within the Clinical Operations function of Late Stage R&D, specifically focusing on BioPharmaceuticals and Oncology. This strategic position oversees one or more clinical programs, including studies at various stages of development, with a particular emphasis on Phase 3 studies or market-ready products. The GPD will work under the guidance of the Senior Global Clinical Operations Program Director (Sr GPD) to provide operational leadership, ensuring that clinical studies meet all deliverables related to scope, quality, budget, time, resource, and risk.

The role requires the integration of strategy, design, feasibility, and operational planning to develop clinical drug development programs aligned with business priorities and strategies. The GPD will also lead cross-functional teams, manage clinical program team activities, and contribute to regulatory submissions and post-registration product maintenance. Additionally, the GPD will drive continuous improvement and change within clinical operations and other business areas.


Key Responsibilities:

  • Leadership and Oversight:
  • Lead cross-functional teams in the planning and execution of clinical studies and activities, ensuring adherence to scope, quality, budget, and timelines.
  • Provide strategic oversight and clinical operations expertise, including country selection, feasibility, design input, risk management, and external partner management.
  • Manage clinical plans and resources, including cost, FTEs, and timelines, using business reporting systems such as PLANIT.
  • Program Management:
  • Oversee the development and execution of clinical drug development programs, incorporating innovative design and delivery models.
  • Serve as the primary point of escalation for study teams and external partners, including CROs, AROs, and other vendors.
  • Lead or support large-scale deliverables and problem-solving efforts, driving operational excellence and timely delivery.
  • Regulatory and Submission Support:
  • Provide project leadership for cross-functional Clinical Submission Teams, ensuring effective planning and execution of clinical contributions to marketing applications.
  • Improvement and Change Management:
  • Lead or contribute to process improvement and change management initiatives within clinical operations and other business areas.
  • Act as an ambassador for new ways of working, championing the implementation of new initiatives and best practices.
  • Team Development:
  • Mentor, coach, and support the development of team members.
  • Promote a culture of motivation and empowerment to achieve individual, team, and organizational goals.


Qualifications:

  • Education:
  • University degree in medical or biological sciences or a related discipline. Advanced degree preferred.
  • Experience:
  • At least 10 years in the pharmaceutical industry or similar multinational organizations, with proven experience in clinical development across various phases and therapy areas.
  • Demonstrated leadership in managing clinical projects and deliverables.
  • Experience with project management tools, processes, and change management methodologies.
  • Desirable:
  • Project management certification (e.g., PMP) and knowledge of process improvement methodologies such as Lean Sigma.

Experience with regulatory submissions

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