Senior Director, Global CMC Lead

12+ years of progressive CMC experience within the pharmaceutical or biotechnology industry, with significant experience supporting small molecule development programs.

Demonstrated leadership of CMC activities across multiple stages of development, including late-stage development and commercialization readiness.

Proven experience supporting global regulatory submissions and interactions with major health authorities, including FDA, EMA, and PMDA.

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

Strong understanding of external manufacturing models, CDMO oversight, and cross-functional collaboration in matrixed environments.

Broad knowledge of global CMC regulatory requirements, GMP expectations, and lifecycle management principles.

We are seeking a strategic, collaborative, and execution-oriented leader for the role of Senior Director, Global CMC Lead.   The Senior Director, Global CMC Lead will provide cross-functional leadership and accountability for defining and executing integrated CMC strategies across development-stage and late-stage small molecule programs.

This individual will partner closely with CMC cross functional teams, Regulatory, Quality, Clinical Development, and external partners to advance programs efficiently from development through commercialization readiness.

Lead and execute integrated global CMC strategies across assigned development programs from early development through commercialization readiness.

Serve as the primary CMC lead on cross-functional program teams, accountable for CMC timelines, deliverables, risks, and strategic alignment.

Drive CMC planning and execution for global regulatory submissions, including INDs, CTAs, NDAs/MAAs, and lifecycle management activities.

Anticipate, assess, and proactively mitigate CMC risks impacting development timelines, regulatory success, product quality, or supply continuity.