Director, Project Office - Marcus Center for Cellular Cures
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Duke University’s Marcus Center for Cellular Cures (MC3) has an immediate opening for a Director, Project Office, MC3. Our Vision: To live in a world where every person has access to high quality and effective cell based therapies Our Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health More information is available at the following link: https://marcuscenter.duke.edu/
This role will direct the MC3 Project Office and oversee several project
manager roles. Responsibilities include overseeing a portfolio of MC3
Strategic Projects to ensure progress towards goals and application of
project management tools to effectively communicate information across the
teams, track progress and develop and implement action plans to
troubleshoot and address issues. This role will organize review meetings and
conduct cross functional team meetings as needed.
- Direct the MC3 Project Office. Supervise the Project Managers (PMs) in
the Office. Provide guidance to PMs and establish overall direction for the
- Manage personnel actions for the Project Office, including, but not limited
to, hiring, performance appraisals, promotions, and vacation schedules
- Oversee portfolio of MC3 Strategic Projects to ensure progress towards
goals. Apply project management tools to effectively communicate
information across the teams, track progress and develop and implement
action plans to troubleshoot and address issues.
- Organize review meetings and conduct cross functional team meetings as
- Proactively increase the productivity, efficiency, and organization of the
projects managed by the Project Office and identify issues that could impact
the successful execution of projects and elevate issues to MC3 Leadership.
Provide suggestions to resolve the problem/mitigate the risks.
- Manage project tracking and program evaluation.
- Provide coordinative oversight to MC3 projects as needed. Advise and
assist MC3 team members in the development of plans, time lines, and
processes for projects as needed.
- Apply project management tools to effectively communicate information
across the teams. Organize review meetings and conduct cross functional
team meetings as needed.
- Provide materials for update to MC3 Leadership. Assist with implementing, maintaining, and assisting management with the balanced scorecard. - Directly manage projects as needed. Portfolio of projects could include clinical trials projects, IT and data management projects, tech transfer projects, process development projects or any other critical project for MC3. a) Clinical trials management: Manage multi-site and single site clinical trials. Negotiate site budgets and contracts, pre-screen clinical sites, write training documents and train processing labs, conduct Site Initiation Visits (SIVs), select and manage CRO and/or contract CRAs, manage the development of data base and CRFs, randomization schedules and modules. Coordinate with Duke legal to set up site contracts as needed. Act as main point of contact for external sites. Act as coordinating center for MC3 multi-site studies. Coordinate among multiple stakeholders to achieve successful study initiation, completion and close out. Coordinate with statistician to create randomization schedules and sampling plans. Manage statistician, Data safety Monitoring Board (DSMB), and data management services to create and review data reports. Write DSMB charter and select and train DSMB members. Coordinate with MC3 manufacturing labs and Duke and external clinical sites, for the distribution of cellular products undergoing testing in MC3 clinical trials. Assist with writing of clinical protocols, INDs, BLA documents. Review regulatory reports, review data submitted to INDs. Monitor status of ongoing trials and outcomes. b) IT and Data Projects Management: Manage IT and data management projects for the Marcus Center for Cellular Cures. Lead the implementation of new software in FDA-regulated, GMP environment to support critical operations of the Center. Select vendors and manage the contracting process. Coordinate with all stakeholders to develop implementation plans. Determine functionality of the new systems and develop procedures and CRFs as needed. Manage migration from existing systems. Oversee implementation of the installation or upgrade. Develop and/or modify SOPs for the new systems and work with the Operations team to update the Operations SOPs as needed. Manage training of personnel on the new systems. Oversee IQ/OQ/PQ, writing and implementing validation plans as needed. Write regulatory documentation as needed for the validation and approval of these systems. Write validation protocols and perform or oversee the performance of IQ/OQ/PQ for these systems. c) Tech Transfer or Process Development Projects: Coordinate cross functional teams to manage progress on projects. Act as main point of contact for key external stakeholders. Develop aims, track progress and manage deviations. Alert senior leadership of problems and develop course of action to address issues. Communicate with all stakeholders.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification.
Project leadership and management experience
Experience in multicenter clinical trials and/or FDA / GMP setting
Demonstrated ability to operationally manage several projects concurrently
Attention to detail, excellent management and relationship skills, ability to work well under pressure
Excellent communication skills, both spoken and written and at all levels of the organization.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Bachelor's degree in English, communications, science, business or a related field. Advanced degree is highly desirable with demonstration of an understanding and familiarity with a broad range of science or technical subject matter.
Seven years of experience working with extramural grants and contracts. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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