Director, CMC Project Management
ProKidney · Winston-Salem
The Director, CMC Project Management owns the integrated Technical Operations plan that carries ProKidney's late-stage autologous cell therapy program through BLA submission, Pre-License Inspection (PLI) and approval, and will establish the CMC program and portfolio management framework (governance, tools, standards and reporting) used across all Technical Operations projects. Working with functional leaders across Technical Operations, Quality and Regulatory, this role manages the dependencies and critical path that cross functional boundaries, runs the operating cadence that keeps the work moving every week, and gives leadership a single, reliable view of where the program stands. The successful candidate has served as project or program manager on at least one BLA submission, understands how FDA expectations shape a late-stage CMC plan, and brings the discipline to run a complex, cross-functional program.
The position reports to the Vice President, Technical Operations Strategy, with a dotted line to Program Leadership & Management (PMO).
Key Responsibilities:
- Translate the CMC strategy into an integrated CMC project plan through BLA submission and Pre-License Inspection, with defined milestones, deliverables, owners, durations and decision points, built with and agreed by the functional leaders who own the work.
- Establish and roll out the CMC portfolio management framework, including governance and stage gates, standard templates, scheduling and portfolio tools, and portfolio-level reporting to leadership.
- Drive cross-functional execution across Technical Operations, Quality and Regulatory, managing inter-dependencies and the critical path, and tracking draft, review and delivery dates for CMC submission content against the plan.
- Proactively identify and prioritize program risks, develop and monitor mitigation and contingency plans, and escalate timeline slips and unresolved dependencies promptly, stating the impact on the filing or inspection schedule.
- Facilitate planning, risk and decision meetings with functional leaders and subject matter experts, drive decisions to closure, and translate outcomes into plan actions with owners and dates.
- Set up and run the weekly operating rhythm: tracker updates, cross-functional check-ins, RAID and decision logs, and consolidated status updates to leadership.
- Lead, develop and manage the project managers supporting CMC projects.
- Communicate clearly with team members and executives through written, verbal and summary updates that give line of sight to key issues, decisions and accomplishments.
Secondary Responsibilities
- Partner with Operations, Quality, Regulatory and other CMC functions to plan, sequence and track late-stage CMC activities and deliverables.
- Through the dotted line to the VP, Program Leadership & Management (PMO), provide CMC plan updates on a defined cadence to feed the Integrated Project Plan (IPP).
Qualifications:
- Education/Training:
- Bachelor's degree in life sciences, engineering, business or a related field, or equivalent experience. PMP or PgMP certification preferred.
- Experience:
- Has served as project or program manager on at least one BLA submission, owning the CMC timeline through submission. Experience supporting Pre-License Inspection readiness and cell or gene therapy experience preferred.
- 12+ years of biopharmaceutical industry experience, including 8+ years in dedicated project or program management roles.
- Working knowledge of biopharmaceutical CMC and regulatory filing timelines, with an understanding of GMP.
- Experience leading and developing a team of project managers.
- Skills/Abilities:
- Has built a project or portfolio management function from the ground up, including governance, tools, standards and operating cadence, and sustained it through delivery.
- Has led cross-functional teams in a remote or hybrid model.
- Proven ability to drive decisions and accountability across functions without direct authority, including with senior leaders and technical experts.
- Understands how FDA expectations for BLA submission and Pre-License Inspection shape a late-stage CMC plan, and builds the plan to meet them.
- Hands-on owner of the plan who builds and maintains schedules, trackers and risk registers personally.
- Proficient in enterprise scheduling and tracking tools, including critical path and dependency management.
- High ethical standards and a strong compliance focus.
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.