Senior Director, Global CMC Lead

The Opportunity:

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.

The ideal candidate will bring deep expertise in small molecule pharmaceutical development and manufacturing, a strong understanding of the oncology drug development lifecycle, and the ability to thrive in a dynamic, fast-paced, and highly collaborative environment.

Responsibilities:

• 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.

• Provide strategic oversight of drug substance and drug product development, manufacturing, analytical development, specifications, and control strategies.

• Partner closely with PDM functional teams and external CDMOs to ensure technical readiness for late-stage development, PPQ, validation, commercial supply, launch readiness, and lifecycle management activities.

• Support supply planning, capacity management, dual sourcing strategies, and risk mitigation initiatives to ensure robust and reliable supply continuity.

• Ensure all CMC activities are conducted in compliance with applicable GMP, ICH, FDA, EMA, and other global regulatory requirements.

• Collaborate closely with PDM functional leaders to define and execute global CMC regulatory strategies and support health authority interactions.

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

• Communicate CMC risks, trade-offs, timelines, investment needs, and program status clearly to senior and executive leadership.

• Support business development activities, including CMC due diligence evaluations and integration planning as needed.

Required Skills, Experience and Education:

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

• 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.

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

• Demonstrated ability to lead through influence and drive alignment across highly collaborative, matrixed organizations.

• Strong scientific and regulatory judgment, with clear and effective communication skills.

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

Preferred Skills:

• Experience in oncology drug development, particularly targeted therapies.

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

• Experience supporting commercial launch activities and post-approval lifecycle management.

• Experience with late-stage development activities, including validation and commercial manufacturing readiness. 

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