Director, Project Office - Marcus Center for Cellular Cures

Job description

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/

OCCUPATIONAL SUMMARY:

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.

WORK PERFORMED:

  • Direct the MC3 Project Office. Supervise the Project Managers (PMs) in

the Office. Provide guidance to PMs and establish overall direction for the

projects.

  • 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

needed.

  • 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.

Preferred skills

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.

Minimum Qualifications

Education

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.

Experience

Seven years of experience working with extramural grants and contracts. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 

 

 

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Job No:
Posted: 4/7/2021
Application Due: 7/6/2021
Work Type: Full Time
Salary: