Associate Director/Director, Development Program Management, CMC

About the role

The Associate Director/Director, Development Program Management, CMC will provide strategic and operational project management leadership for CMC teams, with an initial focus on phase 1 and 2 compounds. This role will drive integrated planning, execution support, governance, and communication across multiple cross-functional programs and initiatives.

Responsibilities

• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Partner with CMC, Development Program Management, Program Team Leaders, and functional stakeholders to translate program strategy into integrated CMC execution plans, project charters, and team ways of working for assigned programs and initiatives.
• Lead project management for assigned CMC activities, including new molecules, tech transfer, scale-up, lifecycle management, and other development initiatives, ensuring alignment of scope, timelines, milestones, dependencies, deliverables, and risks.
• Develop, baseline, and maintain project management tools and reporting, including CMC project plans, dashboards, milestone charts, action logs, risk logs, status reports, and financial tracking, as appropriate.
• Drive team execution and governance through effective meeting management, decision and action documentation, follow-up with accountable owners, and clear communication of progress, risks, issues, and key decisions.
• Monitor project progress, identify risks or execution gaps, and partner with stakeholders to develop mitigation plans, escalation recommendations, and decision-ready updates.
• Improve CMC project management effectiveness through scalable tools, templates, Smartsheet solutions, automation, AI-enabled approaches, and other process improvements that enhance planning, visibility, and execution.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.

Qualifications

• Bachelor’s degree in a scientific, technical, business, or related discipline required; advanced degree preferred.
• Typically requires 8+ years of relevant biotechnology or pharmaceutical industry experience for Associate Director level, or 10+ years for Director level, including significant experience in CMC, pharmaceutical development, technical operations, or related drug development environments.
• Experience supporting small molecule drug substance and drug product development required; experience with API development and solid oral dosage forms strongly preferred.
• Demonstrated experience managing cross-functional CMC deliverables, timelines, risks, and documentation in support of early-stage regulatory submissions, including INDs and/or IMPDs; exposure to NDA/MAA or other late-stage submission activities preferred.
• Proven ability to influence without authority, drive alignment across technical and non-technical stakeholders, and ensure execution discipline across complex, matrixed development teams.
• Strong analytical, facilitation, problem-solving, written communication, and verbal communication skills, with the ability to communicate effectively with both technical and non-technical stakeholders.
• Proficiency with Smartsheet, Microsoft Project, Microsoft Office, and related project management tools required.
• PMP certification or equivalent project management training preferred.