Senior Director, Global CMC Lead

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.

Requirements

• 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.

Qualifications

• 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.

Pay

$244,000 - $305,000 USD