Director, CMC Team Lead

Are you ready to lead the CMC strategy for high-potential therapies and turn scientific promise into first approvals? This is your opportunity to guide an asset across the entire development lifecycle—from Candidate Selection through First Approval—while shaping how we bring life-changing medicines to people with serious, underserved conditions.

As Director, CMC Team Lead, you will run a cross-functional, matrix team that sets the direction for drug substance, drug product, analytical, quality, regulatory, and clinical supply to deliver on critical landmarks! You will craft the CMC Development Plan, drive decisions at pace, and ensure operational execution aligns to strategy, risk, and value. Do you thrive at the intersection of science, operations, and governance, where decisive leadership accelerates patient impact?

Accountabilities:

• Asset Lifecycle Leadership: Own CMC leadership for a defined asset from Candidate Selection through First Approval, ensuring strategy, execution, and risk management stay aligned to program objectives.
• CMC Strategy and Planning: Own the development of the integrated CMC Development Plan, setting clear priorities and team goals that enable timely submissions, clinical starts, and approval readiness.
• Execution and Delivery: Translate strategy into actionable operational plans, define critical paths, and drive delivery across drug substance, drug product, analytical, quality, regulatory CMC, and clinical supply.
• Dependency and Risk Management: Identify key interdependencies across execution teams, proactively manage risks and issues, and advance according to enterprise governance to protect timelines and quality.
• Enterprise Representation and Governance: Serve as the sole CMC point of contact to enterprise Global Product/Medicine Teams and internal governance bodies, providing transparent updates and securing decisions.
• Cross-Functional Decision Making: Facilitate timely, data-driven decisions across all CMC functions, ensuring clarity of responsibilities, deliverables, and success criteria.
• Collaborator Influence and Communication: Build positive relationships across the organization and with senior leaders; communicate succinctly, align team members, and create momentum behind the plan.
• Team Leadership and Culture: Prioritize and encourage a diverse, high-performing team; foster accountability, continuous improvement, and a patient-centered approach.

Essential Skills/Experience:

• Bachelor's Degree with a minimum of 8-10 years of experience in the biopharmaceutical industry, with prior experience in a CMC leadership role
• Demonstrated critical thinking capabilities with forward looking perspective.
• Strong communication, leadership, and collaboration skills are required.
• Solid understanding of drug development and clinic supply processes
• Demonstrated ability to build, coordinate, and lead teams.
• Strong interpersonal skills; proficient and able to influence others in spoken and written English.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience:

• Prior experience as a liaison with corporate partners preferred.
• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, Project, and PowerPoint.
• Knowledge of MS Project Server a plus

When we put unexpected teams in the same room, we ignite ambitious thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Here, you will combine the agility of an entrepreneurial environment with the reach of a global biopharma, working alongside colleagues who value kindness as highly as ambition. We bring diverse expertise together to solve complex problems, stay close to patients’ lived experiences, and turn bold science into meaningful outcomes. You will have the autonomy to move fast, the support of experienced leaders, and access to cutting-edge platforms that help you grow while advancing therapies for people who need them most.

Lead the CMC journey that transforms scientific innovation into approval-ready medicines—step forward and shape what comes next with us today!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.