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Director of Program Management

San Diego, CA

Order: 63973

We are looking for a Director of Program Management for the Research and Development Headquarters of our biopharma company. We are focused on the development of novel synthetic bile acid analogs to treat chronic liver diseases.

 

This position will serve as the lead Program Manager for the Nonalcoholic Steatohepatitis (NASH) Filing and Approval Team, a cross-functional team responsible for the successful, on-time submission of a New Drug Application (NDA) for the treatment of NASH with obeticholic acid (OCA) in the US and a Marketing Authorization Application (MAA) in Europe, as well as additional global regulatory filings. This position will also manage any follow-on activities related to the regulatory submissions or approval processes.

 

ESSENTIAL FUNCTIONS:

 

Partner with the NASH Filing and Approval Team leader and team members to:

Develop and manage an integrated filing plan for the NDA and MAA regulatory submissions, covering the key elements of the submission (Table of Contents), timelines, resource needs, dependencies, risks and mitigation plans * Facilitate NASH Filing and Approval Team meetings:

Ensure collaborative and productive team meetings

Actively manage team meetings, ensure appropriate topics brought to the team for discussion and decision-making

Prepare and distribute team meeting agendas, materials and minutes

Identify action items and manage execution in collaboration with the filing team leader

Prepare and present status reports during filing team meetings

Manage all filing team activities in collaboration with the NASH Filing and Approval Team leader and team members:

Partner with filing team members and functional area heads to develop plans to enable successful and timely completion of filing team activities and deliverables

Actively monitor critical path activities, assess potential risks to the timeline and proactively identify areas for efficiency and process improvement

Ensure seamless communication within filing team, and across related program and cross-functional teams

Participate in the development of presentations and other communication materials for senior management

Manage filing sub-teams, ensure coordination and alignment between the sub-teams and the filing team

Communicate with filing team members to ensure that each team member is aware of both individual and team responsibilities and deliverables

Responsible for development and maintenance of filing timeline/Gantt; identify potential timeline risks, issues, and deviations from plans

Work with the team leader and functional area heads to identify resourcing needs

Manage activities of external vendors and experts, as needed. Ensure vendor-managed activities captured and tracked in the integrated plan

 

QUALIFICATIONS:

 

BS or BA required, advanced degree preferred

Minimum of 10 years of drug development experience is required

Minimum of 5 years of project management experience in the biopharmaceutical industry is required

Prior experience managing NDA submissions and other regulatory filings is required

PMP certification is desirable

 

REQUIRED KNOWLEDGE AND ABILITIES:

 

Ability to understand the science of the indication/therapeutic area and the molecule in order to effectively document issues and agreements

Strong understanding of drug development processes from strategic and operational perspectives (including regulatory understanding, clinical operations feasibility, etc.)

Able to facilitate activities across many disciplines represented on cross-functional drug development teams

Ability to manage and direct work in a matrix environment; ability to work collaboratively across all levels of the organization

Occasional travel (up to 15%)

 

NOTE: Candidates that are offered a position are required to pass pre-employment drug and background screening. Qualified candidates with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

 

Qualified candidates please email your resumes directly to lramirez@suna.com