This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CMC Program Lead based in the United States.
This role sits at the intersection of science, manufacturing, and global program execution, driving the development and delivery of complex radiopharmaceutical products across all clinical stages through to regulatory submission. You will lead cross-functional CMC strategy for innovative oncology and rare disease therapies, ensuring alignment between technical teams, external partners, and global stakeholders. Acting as a key integrator, you will coordinate development, supply chain, quality, and regulatory activities within a highly matrixed environment. The role has direct impact on the successful progression of life-changing precision medicine assets from early development to commercialization. You will operate in a fast-paced, global setting where scientific rigor, program discipline, and collaboration are essential. This is a high-visibility leadership position influencing both operational execution and long-term product strategy.
Accountabilities:
- Lead the planning, coordination, and execution of end-to-end CMC strategies for radiopharmaceutical programs from early clinical phases through pivotal studies and regulatory submissions (NDA/MAA/BLA).
- Serve as the CMC representative within global matrix teams, ensuring alignment across development, supply chain, quality, regulatory, and clinical functions.
- Drive integrated CMC program planning, including timelines, budgets, dashboards, and tracking of key deliverables and milestones.
- Identify, assess, and communicate program risks while developing mitigation strategies in collaboration with internal and external stakeholders.
- Lead and coordinate cross-functional CMC teams and facilitate effective decision-making through structured project management practices.
- Manage relationships with CDMOs/CMOs, including vendor selection, performance oversight, and alignment with program objectives.
- Ensure seamless communication of CMC status updates, KPIs, and forecasts to senior leadership and global stakeholders.
- Oversee documentation, meeting governance, and compliance with SOPs, GxP standards, and regulatory requirements.
- Support development-to-commercial transition planning and ensure continuity across product lifecycle stages.
Requirements:
- 10+ years of experience in pharmaceutical, biopharma, or radiopharmaceutical CMC development, including 5+ years in program or project management roles.
- Strong understanding of CMC processes across drug development, manufacturing, and global regulatory requirements (FDA and other agencies).
- Proven experience working in highly matrixed, cross-functional environments with internal teams and external CDMOs/CMOs.
- Strong technical foundation in pharmaceutical or radiopharmaceutical development, supply chain, or manufacturing operations.
- Excellent leadership, communication, and stakeholder management skills, including experience presenting to senior leadership.
- Demonstrated ability to manage complex programs, timelines, budgets, and interdependencies in a global setting.
- Proficiency with project management and enterprise tools such as MS Project, SAP, Smartsheet, or equivalent systems.
- Strong analytical mindset with the ability to identify risks, drive solutions, and improve processes.
- A collaborative, adaptable, and results-driven approach with strong professional integrity.
Benefits:
- Competitive base salary with performance-based bonuses
- Equity-based incentive program
- Comprehensive medical, dental, and vision insurance
- Generous paid time off and wellness days
- Hybrid and remote work flexibility across global teams
- Learning and development support with ongoing professional growth opportunities
- Participation in a mission-driven organization focused on advancing precision medicine
- Inclusive, global work environment with strong cross-functional collaboration