Director Clinical Operations

Organization
Director Clinical Operations
Job Location
Apply Online
Redwood City, CA 94063
Salary
DOE
Job Description

Genomic Health is seeking a highly talented and motivated Director of Clinical Operations to lead the clinical trials management function for our product portfolio. This is an exciting opportunity to shape our clinical operations during a time of growth and innovation for our company. This individual will manage a team of Clinical Trial Managers and Assistants across our portfolio of products as well as manage select clinical trials directly. This leadership role requires an individual with industry experience in clinical trial management, people management and project planning. This individual will also be responsible for ensuring strong cross-functional partnerships between Clinical Operations and the rest of the organization as well as the planning and adoption of clinical trial management best practices and process improvement within the team as we evolve to meet the coming FDA and relevant European Union requirements for Laboratory Developed Tests.

 

A strong candidate will have a track record of successfully executing complex clinical trials and implementing clinical trial management discipline within an R&D organization for the development of products in a regulated environment. A candidate will also have demonstrated success developing and managing teams and collaborations. This role requires excellent communication and stakeholder management skills, 15+ years experience in clinical operations/clinical trial management, people management experience, and strong leadership skills of both matrixed teams and direct reports.

 

This position in Clinical Operations reports to the Senior Director, Oncology Development.

Requirements
  • Lead and manage the Clinical Operations organization including:
    • Hire, develop and mentor top Clinical Operations talent
    • Develop and manage all aspects of global clinical study processes (GCP SOP's) and practices to ensure GCP compliance and best practices as required
    • Contribute to standardization of practices across departments in collaboration with Regulatory Affairs, Quality and the Clinical Laboratory Operations
    • Conduct ongoing reviews of department Standard Operating Procedures (SOPs) to ensure compliance
    • Develop, implement, and review clinical outsourcing strategies
    • Influence leadership for best practice and resource investments for effective clinical trial management based on data-driven business needs
    • Invest in the Clinical Operations team culture and environment to build high morale and commitment to company, team and individual goals and objectives
    • Assign studies and projects to Clinical Operations staff, providing technical support, feedback and direction
    • Use appropriate project management tools, communication plans and risk management techniques to create rigor in project planning and execution of clinical trials
    • Develop and manage the department budget
  • Provide direct clinical trial management, including:

o Leadership and management of study progress from initiation through publication of results and finalization of study reports, including but not limited to maintenance of the study timeline, management of Investigator Agreements, execution of tasks by functional area, and regulatory and protocol compliance

o Participate in and represent function at study and clinical team meetings

o Ensure the accurate and timely delivery of study-related progress reports to program leadership and senior management

o Coordinate and maintain effective collaborator communications for specimen tracking, study conduct and/or data review, to include but not limited to periodic teleconferences and face-to-face meetings

o Ensure that files for study-related documents are accurate, current and complete

o Prepare study budget and forecasts to Finance and Business Development leaders

  • Additional responsibilities as assigned

REQUIRED

 

  • Bachelor's degree in life sciences, scientific or other relevant discipline
  • Minimum 15 years clinical trial management or related experience in the health care, biotechnology or diagnostics industry, including experience in people management and organization leadership
  • Demonstrated ability and enthusiasm to lead, hire, mentor, develop, retain, and inspire the best talent
  • Demonstrated leadership, implementation, and compliance with GCP processes and practices
  • Demonstrated ability to deliver quality results in a timely manner both directly and through others
  • Demonstrated competency in Microsoft Office tools, specifically Word; Excel; PowerPoint; and/or Project
  • Excellent organization skills and detail orientation
  • Demonstrated competency with standard project management processes and procedures
  • Ability to influence and negotiate with diplomacy in a fast-paced, rapid growth environment using data to drive decisions, including in ambiguous situations, to achieve desired results
  • Able to integrate and apply feedback in a professional manner
  • Ability to work as part of a multi-functional team

 

DESIRED

  • Additional education in life sciences, scientific, clinical trial or project management, or other relevant discipline
  • Experience leading a team through establishment of GCP processes for success in an FDA regulated environment
  • Experience in a CLIA regulated environment

 

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:

 

  • Travel Requirements: 10-20% for partner meetings, professional development or training
  • Standing or sitting for long periods of time may be necessary

 

 

 

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