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Clinical Operations Program Leader

2 months ago

Gaithersburg, Maryland, United States Sunrise System Inc Full time

Job Title: Global Clinical Operations Program Director

Company: Sunrise System Inc

Location: Hybrid Work Environment

Contract Duration: 12 months

The Global Clinical Operations Program Director (GPD) plays a pivotal role within the Clinical Operations sector of Late Stage Research and Development, specifically focusing on Biopharmaceuticals and Oncology. This position encompasses a wide range of responsibilities that may involve one or multiple products, depending on their complexity and scope.

The GPD will oversee products that are either in Phase 3 development or already available in the market, with the potential to include studies across all phases of drug development. Acting on behalf of the Senior Global Clinical Operations Program Director, the GPD will provide strategic operational leadership and management for a suite of global clinical studies within a program, ensuring that all clinical operations deliverables meet the necessary standards for scope, quality, budget, time, resources, and risk management.

Key responsibilities include:

  • Integrating strategy, design, feasibility, and operational planning to create business-focused clinical drug development programs that align with organizational priorities.
  • Developing core clinical operations components for governance interactions under the guidance of the Senior GPD.
  • Leading cross-functional teams in the execution of clinical program team activities.
  • Providing project leadership for cross-functional clinical submission teams to support regulatory marketing applications and post-registration product maintenance.
  • Contributing to improvement and change initiatives within clinical operations and other business areas.

Education, Qualifications, Skills, and Experience:

  • A university degree (or equivalent), preferably in medical or biological sciences, or a discipline related to clinical research. An advanced degree is preferred.
  • A minimum of 10 years of experience within the pharmaceutical industry or similar large multinational organizations.
  • Demonstrated knowledge of project management tools and processes, along with proven experience in the clinical development process across various phases and therapeutic areas.
  • Ability to learn and adapt by working in multiple phases and therapeutic areas, with experience leading clinical projects and deliverables.
  • Strong mentoring and leadership skills, promoting motivation and empowerment to achieve individual, team, and organizational goals.
  • Proficient in change management and continuously seeking more efficient methods for delivering clinical operations components, focusing on key performance metrics.
  • Excellent written and verbal communication skills, with the ability to negotiate, collaborate, and build interpersonal relationships at all organizational levels.
  • Proven ability to set and manage priorities, resources, performance targets, and project initiatives in both regional and local contexts.
  • High integrity and ethical standards.
  • Exceptional stakeholder management capabilities.
  • Adaptability to changing environments.

Desirable Qualifications:

  • Project management certification is advantageous but not mandatory.
  • Familiarity with process improvement methodologies such as Lean Sigma or Change Management is a plus.
  • Experience in regulatory submissions and knowledge of clinical operations.
  • Experience in developing and implementing digital health initiatives in clinical studies.