Executive Director, Global CMC Lead

The Opportunity:

We are seeking an accomplished, strategic and execution-oriented leaders, Executive Director, Global CMC Lead, reporting to SVP of Pharmaceutical Development and Manufacturing (PDM).  The Executive Director, Global CMC Lead provides enterprise-level leadership and accountability for defining and executing the global CMC strategy across the development and commercialization lifecycle. This role sets technical and regulatory direction for late stage and commercial programs, ensures supply continuity, and partners closely with Development, Regulatory, Quality, and Commercial leadership to enable rapid, compliant, and scalable product advancement globally.   The role combines deep technical credibility in small molecule development with strong strategic judgment, people leadership, and external influence.  The role requires expertise in small molecule pharmaceutical development and manufacturing, an understanding of the oncology development lifecycle, and the ability to thrive in a dynamic, fast-paced environment.

Responsibilities:

• Own the integrated global CMC strategy across assigned development and commercial programs

• Serve as the senior CMC leader on program and portfolio teams, accountable for CMC timelines, risks, and deliverables.

• Drive clear, risk-based CMC decision-making that balances speed, quality, and long-term product robustness.

• Anticipate and proactively manage CMC risks impacting development speed, regulatory success, or supply robustness.

• Provide strategic oversight of drug substance development and manufacturing, drug product development and manufacturing, specification and control strategy development, and lifecycle optimization.

• Partner with PDM cross-functional team / leadership to ensure technical readiness for late-stage development, PPQ, validation, and commercial supply, capacity planning, risk mitigation, dual sourcing as needed, and launch readiness, as well as life cycle development.

• Partner with PDM cross-functional team / leadership to define global CMC regulatory strategy for IND/CTA, NDA/MAA, JNDA and post-approval lifecycle activities.

• Provide senior-level review and approval of CMC content for global submissions and health authority interactions.

• Ensure all CMC activities meet global GMP, ICH, and regulatory expectations.

• Act as a strategic partner to Clinical Development, Regulatory, Quality, Nonclinical, and Commercial leadership.

• Clearly communicate CMC risks, trade-offs, timelines, and investment needs to executive leadership.

• Support business development due diligence and integration from a CMC perspective.

Required Skills, Experience and Education:

• PhD (strongly preferred), MS, or equivalent in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline.

• 15+ years of progressive CMC experience in the pharmaceutical or biotechnology industry, with a strong focus on small molecules.

• Demonstrated leadership of CMC activities from early development through commercialization life cycle.

• Proven experience leading global regulatory submissions and interacting with major health authorities (FDA, EMA, PMDA).

• Deep expertise in small molecule API and drug product development, manufacturing, and control strategies.

• Strong understanding of external manufacturing models and CDMO governance.

• Broad knowledge of global CMC regulatory requirements and lifecycle management.

• Strategic, enterprise-minded leader with strong decision-making and risk management capabilities.

• Proven ability to lead through influence in highly matrixed environments.

• Clear, decisive leadership style with strong scientific and regulatory judgment.

• Ability to operate effectively in a fast-paced, highly collaborative, and data-driven environment.

Preferred Skills:

• Oncology drug development, particularly targeted therapies.

• Experience supporting accelerated development timelines and first-in-class programs.

• Experience with commercial launch and post-approval lifecycle management. 

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