Associate Director, Program Management (Gene therapy)

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

For further inquiries regarding the following opportunity please contact our Talent Specialist Remy at

Title: Associate Director Program Management (Gene therapy)
Duration: 6 Months
Location: Research Triangle Park NC

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Description:

The Associate Director Program Management plays an integral role in advancing clients gene therapy products through clinical development. They will provide comprehensive program management and operational support for the Integrated Product Team (IPT) including creation and maintenance of integrated end-to-end development plans and timelines. This role partners with the IPT Lead to ensure the program team has clear direction and alignment to execute critical activities ranging from pre-clinical (IND-enabling) studies up through BLA submission (e.g. CMC regulatory clinical medical).

Responsibilities

In partnership with the IPT Lead define scope objectives and deliverables for product candidates in stages of clinical development

Create and maintain integrated development plans that accurately capture timelines decision points (i.e. stage gates) resource needs and budget for multiple clinical programs

Track and coordinate critical activities required to advance programs into early-stage and/or registrational clinical studies

Provide general operational support to the IPT including risk identification/mitigation problem-solving communication and contingency planning

In partnership with IPT lead ensure the team is prepared for stage-gates and governance interactions including content development stakeholder management and pre-reads

Deliver timely updates to key functional stakeholders leadership and governance boards covering program status risks/mitigation scope changes etc.

Document IPT meeting minutes key decisions risks/issues and action items

Ensure the team communicates effectively and collaboratively implementing team building techniques where needed to establish and maintain a high-performing teams

Facilitate creation of program budgets resource models and long-range plans

Define resource needs (FTEs and financial) for each stage of development

Ensure all critical program documentation is organized accessible and archived

In partnership with the PM Center of Excellence develop implement and champion PM best practices processes and strategies within the IPT and supporting functions

Assist with implementation of stage-gates and IPT operating model including education to the organizations through functional team sessions and meetings with stakeholders/teams

Required Education and Experience

Bachelors degree in a technical or life science discipline

5 years of experience within the pharmaceutical/biotechnology industry

5 years of project/program management experience

Excellent written and verbal communication skills with the ability to communicate effectively across disciplines and experience levels including executive management

Experience in planning and/or managing cross-functional aspects of biopharmaceutical product development including translational and clinical studies

Experience with SmartSheets and/or other project planning/management software

Ability to mentor lead and/or influence partners in a matrixed environment

Previous exposure to budgeting and resource management processes

Preferred Experience and Skills

Advanced degree (e.g. Masters or Doctorate) in a technical or life science discipline

Project Management Professional (PMP) or an equivalent certification

Prior experience with developing advanced therapies (e.g. cell or gene therapy)

Experience working on/with global teams

Understands and interprets technical data related to biopharmaceutical product development

About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.

For further inquiries regarding the following opportunity please contact our Talent Specialist Remy at Title: Associate Director Program Management (Gene therapy) Duration: 6 Months Location: Research Triangle Park NC Only W2 candidates are eligible for this position. Third-party or C2C ...