Associate Director Clinical Operations | GenomeWeb

Associate Director Clinical Operations

Genomic Health
Job Location
Redwood City, CA 94059
Job Description

The Associate Director of Clinical Operations at Genomic Health, Inc. (“GHI”) is responsible for managing the operational implementation and execution of studies to support the development and commercialization of novel genome-based assays which lead to improved treatment decisions for patients with cancer. This position will also facilitate investigator and other collaborative studies to support the use of the commercialized assays.


The Associate Director, Clinical Operations is expected to provide functional expertise to, and project planning and management for study and clinical teams.


The Associate Director, Clinical Operations serves as the Point of Contact for individual Product Programs.


The Associate Director, Clinical Operations will share his or her expertise to mentor others and establish best practices and/or process improvement within the Clinical Operations organization and may have direct management responsibilities for junior level CTMs and/or Clinical Trial Assistants (CTA).


He/she will have core responsibilities in Design Control as it relates to the submission of products to regulatory agencies.


This position in Clinical Operations reports to the Director, Clinical Operations.


· Demonstrate expert working knowledge of GHI study initiation, execution, analysis and closing procedures; study-related documentation; and study, program and business goals and milestones;

· Evaluate, recommend and present best practices and process improvements to program and/or Clinical Operations leadership to improve efficiency and effectiveness of study initiation and execution;

· Participate in Standard Operating Procedure (SOP) development, training, and implementation

· Monitor study progress from study initiation through publication of study results, including but not limited to maintenance of the study timeline, execution of actions by study team, and regulatory and protocol compliance;

· Guide junior CTM's on Good Clinical Practices (GCP), monitoring activities, and compliance.

· Ensure the utilization of project management tools and best practice processes and procedures, to support efficient and effective study execution;

· Lead study and clinical team meetings; provide direction to CTAs to coordinate study and team meeting details;

· With study team members, identify and prioritize potential problems, challenges and solutions relative to program and business goals;

· Use judgement to identify and present study problems, challenges and recommended solutions requiring escalation to clinical and program team leaders;

· Facilitate the development and timely completion of study-related documents, including but not limited to protocols; and data management and analysis plans;

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

· Lead effective collaborator communications for specimen tracking, study conduct and/or data review, including written communication, teleconferences and face-to-face meetings;

· Prepare budget and forecasts to Finance and Business Development leaders;

· Participate in assessment and recruiting new Clinical Operations team members;

· Mentor junior CTMs and CTAs; may directly manage lower level Clinical Operations staff including hiring, goal setting, coaching and development activities;

· Other responsibilities as assigned



· Bachelor's degree in life sciences, scientific or other relevant discipline;

· Minimum 12 years related experience in the health care, biotechnology or diagnostics industry;

· Minimum of 3 years of experience in an IVD or Medical Device regulated environment at a Clinical Trial Manager level or above.

· Demonstrated competency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint; and Project;

· Demonstrated excellent oral, written and presentation communication skills at all levels in the company;

· Demonstrated ability to influence and lead others to deliver quality results in a timely manner in both independent and team environments;

· Demonstrated excellent organization skills and detail orientation;

· Demonstrated competency with project management processes and procedures;

· Demonstrated ability to be highly effective and influential in a fast-paced, rapid growth environment;

· Able to integrate and apply feedback in a professional manner;

· Ability to work as part of a multifunctional team




· Post-graduate course work in a life sciences, scientific or other relevant discipline;

· Ability and enthusiasm to lead, hire, mentor, develop, retain, and inspire the best talent

· Prior experience managing employees




  • Travel Requirements: annual average of 10-20% travel; travel needs may include peak periods driven by study phase;
  • Standing or sitting for long periods of time may be necessary
  • Use of computer and/or telephone for long periods of time may be necessary
  • Considerable periods of time may be spent concentrating and or analyzing data
  • At times, stress may be experienced




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