Manager, Clinical Operations

Location
Redwood City, California
Posted
Feb 15, 2018
Required Education
Bachelors Degree
Position Type
Full time

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

-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