CMC Project Management & Strategic Operations Director

The Project Management and Strategic Operations Director leads large-scale, high-value CMC programs end to end, setting a high standard for decision quality, governance, risk management, and execution. This role combines deep program management discipline, technical and business judgment, and strong stakeholder leadership to drive planning, delivery, adoption, and continuous improvement across the function. The Director also coaches teams, strengthens project management capability, and serves as a trusted partner on complex internal and external programs.

• Scientific Knowledge/CMC Expertise

• Demonstrates strong command of planning and executing CMC programs to guide teams toward phase-appropriate, risk-based technical approaches.

• Recognizes as a go-to partner for scenario planning of complex CMC topics and understands impacts/trade-offs of technical changes across CMC disciplines.

• Helps teams converge on scientifically defensible paths under uncertainty in preparation for governance decision making.

• Anticipates downstream clinical, regulatory and manufacturability implications relative to the CMC strategy.

• Program/Project Management Expertise

• Leads complex technical decision-making by applying systems thinking, risk-based planning, and scenario analysis. Anticipates ambiguity and structures work to maintain momentum and optionality. Observable behaviors:

• Proactively identifies cross-functional and lifecycle risks.

• Translates uncertainty into executable scenarios and decision trees.

• Leads issue resolution efforts spanning multiple functions and sites.

• Business Acumen

• Leverages understanding of financial processes (e.g. LRP, AOP, BvA), company business statements, NPV and ROI calculations and applies to projects. Understands competitive landscape, customer needs and industry trends in context of projects/programs.

• Drives connections between daily personal and project/program team actions with company goals and functional objectives.

• Influences how departments across the company collaborate to deliver value.

• Guides teams on how best to apply the drug development/combination product process and commercialization to daily project/program planning and execution.

• Leverages complex CDMO management principles and KPIs to measure progress within projects/programs.

Key Duties and Responsibilities:

Leads program initiation, planning, governance, execution, and performance tracking across complex strategic programs. Oversees scope, timelines, budget, risks, issues, dependencies, stakeholder communication, and resource alignment to ensure delivery of business value. Provides direction to workstream leads and project managers, resolves escalated issues, supports sound decision-making in ambiguity, and helps ensure programs are delivered on time, within budget, and in alignment with company standards and objectives.

• Oversees end-to-end program management activities for large-scale, strategic programs of high business value, with oversight for the full project lifecycle

• Manages the progress and contributions of workstream leads or subordinate project managers to ensure all activities deliver expected value within committed timeframes and budget

• Manages contingencies between multiples projects and monitors interdependencies and synergies where required

• Builds and synthesizes highly-detailed project plans, budgeting & forecasting models or resource plans, requiring significant stakeholder management skills and interpretation of diverse and varied information

• Develops statements of work, stakeholder management plans, guiding principles, project goals, risks, resource allocation, and roles and responsibilities for assigned projects

• Secures, leads, motivates and inspires the internal and external resources required to effectively deliver the program. Establishes the program's governance (e.g., sponsors, approvers, stakeholders)

• Participates in the evaluation, selection and management of external resources or vendors

• Provides transparency in project progress and effectively anticipates and mitigates major risks across the project lifecycle

• Proactively crafts feasible solutions to combat risks and issues. Exercises sound judgement balancing risks and making prompt decisions in ambiguous or difficult situations

• Manages communication with management at a detailed functional level and discusses/resolves issues

• Works with all required functions and groups to effectively plan and execute the program/project(s). May coordinate resources across organizational boundaries

• Trains and coaches project teams in execution methodologies and promotes adoption of best practices

• Develops tools and training methods to enable successful project management throughout the enterprise. Ensures project delivery is in conformance with company methodologies and standards; recommends improvements and changes as necessary

• Evaluates program costs and benefits including actual results and forecasts with comparisons to original or baseline plan and updates plans with accurate, up-to-date information in a timely manner. Reports financial information and status to leadership. Ensures program solution(s) meets quality and reliability requirements and that the launch approach meets or exceeds adoption targets. Monitors program results/performance for significant deviations, evaluates options and makes recommendations for corrective actions, and then implements selected actions

Knowledge and Skills:

• Strong experience leading cross-functional, medium- to large-scale programs and projects

• Strong critical thinking and the ability to connect people, ideas, and data to drive outcomes

• Proven ability to work effectively across functions, teams, and organizational boundaries

• Ability to manage multiple priorities while maintaining timelines, budgets, and clear status reporting

• Excellent communication skills, including the ability to synthesize complex information into clear insights and recommendations

• Strong program and operational management skills with attention to detail

• Comfort working in ambiguity and leading teams through complex decisions and change

Education and Experience:

• Bachelor's degree

• 10 years of experience or the equivalent combination of education and experience

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