Program Manager III - Contract

TalentBurst, Inc.

Remote, NC(remote)

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JOB DETAILS

SKILLS

Best Practices, Biology, Biotech and Pharmaceutical, Budgeting, Clinical Trial, Communication Skills, Content Development, Contingency Plans, Contract Management, Cross-Functional, Documentation, Drug Development, Gene Therapy, Internet/IP Telephony, Leadership, Medical Products, Meeting Minutes, Mentoring, Operational Support, Organizational Skills, Pre-Clinical, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Project Management Professional (PMP), Project Planning, Project/Program Management, Regulations, Resource Management, Risk Analysis, Risk Management, Team Building, Time Management, Writing Skills

LOCATION

Remote, NC

POSTED

3 days ago

Program Manager III
6 Months
Remote

Description:
The Associate Director, Program Management plays an integral role in advancing 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
Bachelor s 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., Master s 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 the Company

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.talentburst.com/