Director, Program Management
Director, Program Management
Vital Therapies, Inc. is hiring a Director, Program Management! We are an exciting life science company located in the Carmel Mountain Ranch area of San Diego. Vital Therapies is a pioneer and recognized world leader in the treatment of acute liver failure.
Under the direction of Executive Director, Regulatory Affairs, the Director, Program Management will develop and maintain detailed timelines for regional and cross-regional regulatory activities and submissions. The incumbent will apply advanced project management expertise and regulatory skills to support cross-functional teams in meeting submission goals and coordination of activities in a matrixed team environment. Responsibility for project management of regulatory submissions involving the coordination, prioritization and tracking of regulatory activities and submissions associated with the research, development, and operations as related to Vital Therapies, Inc. new original market application(s) and all IND submissions to the U.S. and worldwide health agencies.
Essential Duties and Responsibilities include, but are not limited to:
• Responsible for the coordination, prioritization and tracking of regulatory activities and submissions associated with the company’s development and eventual post-marketing activities.
• Maintain ownership of the BLA master timeline in MS Project (or comparable software) ensuring timely updates to the GANTT chart and effectively communicating where delays in dependencies impact the overall timeline.
• Create and maintain regulatory timelines, and associated resource needs, and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management
• Track submission preparation progress in order to manage submissions for the original market application (BLA), including monitoring/tracking regulatory commitments and timelines for maintenance activities such as IND Annual Report, DSUR, IND Amendments, Post-Marketing Commitments and follow-up measures ensuring timely filing to health authorities.
• Facilitation of team meetings as necessary (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required).
• Act as a conduit of information and maintains strong collaborations between assigned cross-functional submission teams and the Regulatory Team.
• Foster effective and productive communications among various functional groups including CMC and Clinical Regulatory Leads, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, Quality, Manufacturing, Medical Affairs, and representatives from other departments as appropriate.
• Assure regulatory submissions are prepared in high quality manner according to defined Corporate or Regulatory timelines, and for working with Regulatory Leads (Clinical or CMC) to assure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
• Comply with U.S. FDA and international regulations, other regulatory requirements, VTL policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of personnel, customers, contractors, and vendors.
• May assist with project management for regulatory audits and inspections.
Education and Experience
- Bachelor’s degree in a relevant discipline with 5-7 years of relevant experience for Manager, 7-10 years for Sr. Manager-Associate Director, 12+ years for Director
- Strong Project Management skill sets with focus on biologics and combination products, being familiar with US device regulations desired
- Prior NDA/BLA filing experience desired
- Proficient in MS Suite, especially MS Project, XL Spreadsheet and PowerPoint highly desired
- Excellent verbal, written, negotiation and interpersonal communications skills are required
- Excellent organizational skills and ability to work on a number of projects with tight timelines are required
- Working knowledge of regulatory requirements specific to US and EU, and preferably have a general awareness of requirements for other regions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Regularly required to sit and talk and hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. Occasionally required to stoop, kneel, and lift up to 50 pounds. Frequently required to work on a computer up to 8 hours a day.
Location: Carmel Mountain Ranch, CA
Vital Therapies, Inc. offers a fast-paced work environment, competitive compensation, and generous group benefits
Equal Opportunity Employer