Director, Early Phase Project Management

Location
San Diego, CA
Posted
Oct 22, 2018
Required Education
Bachelors Degree
Position Type
Full time

JOB DESCRIPTION

The Director, Early Phase Project Management will be responsible for project managing Organovo’s therapeutic development programs and will play a key role in driving preclinical assets into the clinic.  The position will work closely with project team members representing preclinical, clinical, regulatory, operations, CMC, quality, legal, and finance departments in a collaborative environment to ensure effective and timely outcomes in all phases of a project from pre-IND to Phase 3.  Will apply best practices in the development of integrated project plans and tracking of key project deliverables and timelines.  Will provide regular progress updates to Senior Management regarding deliverables, timelines, and budgets. 

Director, Early Phase Project Management Responsibilities:

  • Develop, track, and report on detailed project plans, milestones, key activities, progress, and adherence to budget
  • Take a lead role in developing specific resource allocation (person(s) responsible) for all preclinical and clinical stage programs
  • Work with preclinical, clinical, CMC, and operational teams to identify critical issues, critical path, and project overlap
  • Provide and manage regular program-wide dashboards for each development program, and provide regular reports (both formal and informal), to Senior Management
  • Work closely with cross-functional teams to manage the timelines and coordinate the compilation of the Company’s regulatory filings (including pre-IND and IND filings)
  • Facilitate project team meetings, sub-team meetings, and cross-functional information sharing to ensure alignment
  • Identify resource constraints, conflicting priorities among projects, and facilitate discussions tradeoffs, risks, and contingency plans  
  • Attend and record project team meetings including critical issues, actions and responsibilities, and generate meeting minutes
  • Participate in vendor selection, budgeting, contract review, associated project tracking, and selected vendor management
  • Input into/writing of key sections of regulatory documents (as required)
  • Other Duties as assigned

 Director, Early Phase Project Management Skills and Experience:

  • Minimum six years of experience working in project management in an IND preparation setting
  • Bachelor’s Degree in a scientific field is required; Master’s degree preferred
  • Experience in managing early stage development programs is essential (i.e., pre-clinical through Phase I/II). Experience in managing through Phase 3 would be a plus
  • Experience with a cell therapy or regenerative medicine product is preferred
  • Demonstrated experience within a regulated environment and knowledge of cGXPs, regulations, and validation standards
  • Ability to operate both strategically and tactically
  • Proactive, action oriented, and outcome focused
  • Excellent management, leadership, interpersonal, and communication skills

 DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by incumbents assigned to this job. This is not intended to be an exhaustive list of all the functions, responsibilities, duties and skills required for the position, and Organovo retains the discretion to modify functions, responsibilities, duties and skills at any time, including modifying the time devoted to such activities, deleting activities, and assigning other activities.

Organovo is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 858-224-1000 for assistance. #CB