Manager, Clinical Operations

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