The Sr. Director CMC PM will serve as the project management leader and implement project management tools at our manufacturing site located in Winston-Salem, NC. This is a visible position with responsibility for leadership and continuous management of CMC programs leading to operational success within ProKidney.

Working across team structures at the manufacturing site, this individual will:

1. Work with the Site Leadership Team and external stakeholders to identify and prioritize key strategic operational objectives for the site.
2. Ensure measurable definition and progress towards the identified key objectives.
3. Serve as the project leader for specific and diverse CMC projects and processes.
4. Ensure effective resource planning and timely execution of program deliverables.
5. Ensure effective coordination of project activities and meetings.
6. Prepare routine communications and updates to senior management.

The Program Management CMC Lead will work closely with the Head of Technical Operations and Head of Program Management and is responsible for the development and integration of strategy into the site master plan.  The CMC PM will provide operational leadership by working with functional partners and team representatives to deliver robust, fit for purpose plans. Additionally, the PM Lead will provide program support for completion of relevant Chemistry, Manufacturing and Controls sections for Prokidney regulatory filings, as well as monitor and oversee the execution of product lifecycle projects while identifying and communicating issues and risks and developing mitigation strategies.

Ideal candidates will demonstrate strength in communication and organizational skills to succeed in a role that is highly cross-functional and broadly engaged across the company. In this position the identified candidate will bring strong drug development program management experience (cell/gene therapy and/or biotherapeutics experience required) and the ability to build and deploy tools and best practices to ensure the successful execution of program management responsibilities at a rapidly growing organization.

Responsibilities:

• Partnership with Functional Team Leaders to manage cross-functional project teams, establish project goals and milestones, set scientific direction, and establish the development path.
• Partner with functional team leadership to establish strong understanding of vision, purpose and expected results and work collaboratively to ensure measurable goals and objectives are defined across functions and aligned with vision.
• Work within the Program Management Team to develop and translate CMC project planning and strategy into a robust, competitive development plan of key cross-functional program related activities and milestones including identification of critical path activities.
• Support the development of an integrated corporate development plan and target product profile.
• Provide leadership of CMC project teams by overseeing project execution – manage team meetings, including agendas, stakeholder management, and documentation of actions/decisions.
• Define opportunities for acceleration and manage the assumptions regarding human resources, risk, and resources required to accomplish certain gains in time.
• Proactively identify and escalate business issues and consider options to manage implications and risks on project timelines and goals.
• Monitors progress against approved project plans to note deviations and suggest corrective actions.
• Integrates activities with all functional lines to create alignment of program development plans with functional area plans.
• Support scenario planning to support robust decision making through in-depth analysis of program activities.
• Support decision-making on programs and execution of agreed upon program plans, manage team accountability, cross-functional integration, and overall program transparency.
• Utilize effective communication skills to facilitate appropriate information exchange between functional lines, asset lead, core teams and senior management.
• Support organization-wide corporate and strategic planning activities.

Competencies:

• Demonstrated leader with prior CMC experience in cell therapy who exhibits effective communication, EQ, and influencing skills, within a matrix operating environment.
• Demonstration of strategic thinking and planning while also balancing the ability to manage and execute to operational/CMC details.
• Ability to effectively manage multiple projects with competing priorities.
• Strong collaboration and teamwork capability and demonstrated capability to lead with ProKidney leadership principles of Transparency, Respect, Accountability and Collaboration

Minimum Qualifications:

• 8+ years experience in the biopharmaceutical industry supporting late-stage clinical trials
• Undergraduate degree required / advanced degree a plus in life science e.g., bioengineering, biomedical engineering, cell / microbiology, etc.
• Multi-disciplinary biopharmaceutical drug development experience required
• Direct experience in biopharmaceutical CMC / Tech Ops Project Management required.
• Extensive knowledge of project management processes, tools, templates and management techniques required.
• Strong experience with Project Management planning tools such as MS Project or Smartsheet,
• Exceptional computer proficiency – advanced knowledge of MS-Office applications required (including Word, PowerPoint, Excel, and Project).
• Ability to create and deliver presentations to key stakeholders that effectively communicate key findings and summarize insights and implications to communication strategies.
• Strong understanding of risk, budget and resource management.
• PMP certification a plus