Title: Associate Director, Scientific Project Leadership  

Responsibilities:

This position will be responsible for managing the execution of cell therapy projects, including cross-functional planning and execution, aligning scientific and therapeutic strategy, early phase development, CMC, and regulatory filing to enable accelerated FDA approval and patient access to life-saving therapies. Prior experience leading and managing complex and cross-functional projects is required, and a strong understanding of CMC and drug development is preferred. This role will report to the Head of Project and Alliance Leadership.

• Directly manage multiple development projects, leading cross-functional teams through strategy, planning, and execution of projects, and driving these projects to IND filing and first in human clinical trials.
• Project leadership will encompass cell therapy programs developed in collaboration with MDACC faculty and biotechnology companies.
• Drive novel cell therapy projects through IND studies to first-in-human clinical trials, leading at least two programs to the clinic over the first 12 months.
• Coordinate development activities to ensure a high-quality process and assays are ready for Manufacturing and QC on time.
• Oversee the transition from Development into Manufacturing and the execution of supportive engineering runs.
• Coordinate functional groups with Regulatory to generate pre-IND and IND submissions, and those regulatory strategies are communicated.
• Manage the alliance with partners developing innovative, curative cell therapies. Use scientific knowledge and thinking to propel projects through execution.
• Prepare, track and report project scope of work, project plans, and budgets.
• Monitor project progress and ensure execution and accountability within the team.
• Proactively identify project issues, potential risks, and delays, and provide strategies for risk mitigation.
• Clearly and effectively communicate project progress and provide visibility to the project team, functional heads, senior management, and external partners.
• Contribute to the organizational and project governance structure:
• Provide visibility across projects and departments.
• Facilitate and support project transitions between departments to move projects from development space into the GMP environment and through IND submission.
• Other duties as required            

Qualifications/Skills:

• Bachelor’s degree or Master’s in engineering, science, or related field required. Ph.D. preferred.
• 12+ yrs. of relevant work experience, including six years of project leadership/ management in cell therapy or a closely related field or equivalent combination of education and experience.
• Demonstrate familiarity with Biologics development to IND, required.
• Previous experience with Cell Therapy manufacturing is preferred.
• High level of communication skills required, both written and verbal.
• Demonstrate organization, focus, and diplomacy skills.
• Demonstrate a high level of emotional intelligence and the ability to create a collaborative, trusting team.
• Possess a mindset focus on strategic thinking, data-driven decision-making, and effective communication.
• Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint.
• Previous experience with matrix and agile project management is beneficial.
• Ability to work onsite as needed (remote candidates will be considered with some travel required 25% of the time), relocation preferred.