Director, CMC Lead

About the role

The Stoke Therapeutics team is seeking an experienced and driven Director, CMC Lead to lead cross-functional teams that are accountable for chemistry, manufacturing, and controls (CMC) product lifecycle management.

Key Responsibilities

• Provide technical and strategic leadership to cross-functional CMC development teams accountable for one or more early- and late-phase programs.
• Define, own and maintain a long-term development, manufacturing, and supply strategy for assigned programs, encompassing early- and late-stage CMC development, process validation, commercial readiness, product launch, and post-approval lifecycle management.
• Partner with Manufacturing and Supply Chain to ensure manufacturing capacity and network strategies are in place to meet clinical and commercial demand.
• Identify and lead the assessment of technical, regulatory, quality, logistical, and financial risks associated with CMC development, manufacture, and supply, and develop corresponding mitigation strategies.
• Represent CMC on Program Teams for assigned products, serving as the primary CMC voice in the cross-functional program governance.
• Develop long-range technical strategies to enable CMC delivery against Program Team objectives.
• Lead commercial product CMC lifecycle activities, including post-approval change management, product risk management, robustness improvements, and continuous improvement initiatives.
• Drive the creation of integrated commercial readiness plans to enable global regulatory submissions and product launches.
• Cross-functional review and approval of critical product related documents including: IND/IMPD, NDA/MAA, meeting briefing documents and other regulatory documents.
• Scale up and tech transfer protocols, Pharmacy Manual, Comparability plans/reports, Justification of Specifications, Process Characterization and Validation documentation, Commercial Process Control Strategy.
• Author and review relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
• Provide coaching and mentoring to CMC core team members.

Required Skills & Experience

• Bachelor's degree in biochemistry, chemical engineering, pharmaceutical sciences, or a related field required; advanced degree (MS or PhD) strongly preferred.
• 10+ years of progressive industry experience in CMC development, including significant direct experience with drug-device combination products (e.g. pre-filled syringes, autoinjectors, or similar parenteral delivery systems).
• Minimum 5 years of leadership experience within a CMC function in biologics, oligonucleotides, or advanced therapeutics.
• Experiential breadth across two or more technical functions (e.g., process development, analytical development, manufacturing, regulatory CMC, or quality).
• Demonstrated experience leading and aligning cross-functional technical teams in a matrixed organization.
• Proven track record of leading and aligning cross-functional technical teams in a matrixed organization.
• Proven experience authoring and leading CMC sections of global regulatory submissions, including INDs/IMPDs, BLAs/MAAs/JNDAs, and post-approval filings.
• Excellent communication and interpersonal skills, with demonstrated ability to facilitate. constructive problem-solving and drive decisions across functions and organizational levels.
• Strong working knowledge of QA and regulatory requirements for late-stage clinical and commercial manufacturing, including cGMP, ICH, FDA, and EMA guidelines.
• Broad understanding of CMC development and compliance requirements across analytics, process development, manufacturing, regulatory CMC, and quality assurance.
• Proven experience managing multiple priorities, navigating ambiguity, and working effectively in a fast-paced, dynamic environment.