Manager, Clinical Operations

Department
Clinical

Location
Redwood City, CA

Summary Description
The Manager, Clinical Operations will report to the Senior Director, Clinical Development, and will be responsible for planning Phase I to Phase IV clinical trials of PaxVax's development-stage and licensed vaccines. The Manager, Clinical Operations is expected to perform hands-on clinical operations activities with minimal supervision, as well as provide leadership, supervision, and technical guidance to Clinical Research Associates, Clinical Trial Assistants, and contract Clinical Operations personnel.

Responsibilities:

-Clinical trial execution and oversight:

  • Oversee implementation of clinical trials by managing the timeline, resources, budget, and staff of clinical activities to achieve the study objectives
  • Write clinical protocols and protocol-associated documents including Informed Consent Forms, Clinical Monitoring Plans, and other documents as needed or requested
  • Build and maintain relationships with Contract Research Organizations, travel to sites/investigate sites
  • Supervise study team members including Clinical Research Associates and Clinical Trial Assistants
  • Develop study feasibility and cost estimates for outsourced clinical operations activities; manage external vendors including monitors and contract laboratories

-Interface effectively with other groups within the organization:

  • Work with Senior Management to develop and achieve corporate goals within the expected time frames
  • Work closely with Biostatistics and Data Management personnel on clinical data activities including case report form design and data cleaning
  • Work closely with Immunology personnel on clinical laboratory activities including specimen management
  • Collaborate with Supply Chain personnel to produce investigational product forecasts and identify distribution, storage, and accountability requirements
  • Collaborate with Finance personnel to provide financial information related to clinical development, including budget forecasts.
  • Participate on core project teams and study teams as needed or requested

-Ensure appropriate trial operational infrastructure:

  • Assist in developing staff and creating a desirable work environment in order to attract and retain qualified clinical operations professionals
  • Ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
  • Evaluate and implement tools and processes to improve operational efficiency

Technical Skills and Knowledge:

  • Strong communication skills (verbal and written); effective in interaction with senior and junior colleagues
  • Current knowledge of FDA and ICH GCP regulations and guidelines
  • Software knowledge:  Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe Professional
  • Good judgment and problem solving skills
  • Ability to think strategically and tactically in order to prioritize and delegate tasks
  • Entrepreneurial spirit with “can do” attitude and initiative

Qualifications:

  • BA/BS degree or higher, preferably in the life sciences
  • Minimum of 7 years prior relevant experience in the pharmaceutical/biotech industry or relevant clinical research organization, with a minimum of 2 years management experience
  • Experience building clinical operations groups and associated infrastructure
  • Experience managing Clinical Research Associates
  • Demonstrated project management/clinical operations experience and leadership skills (e.g. managing cross functional study teams, managing outside collaborators)
  • Vaccine clinical trial experience highly desirable
  • Medical writing experience (clinical study reports, publications) highly desirable

Travel:

  • Domestic and International travel may be necessary
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