CMC Project Management & Strategic Operations Director

The Project Management and Strategic Operations Directorleadslarge-scale high-valueCMCprograms endto 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 alsocoachesteams strengthens project management capability and serves as a trusted partner on complex internal and external programs.

• Scientific Knowledge/CMC Expertise

• Demonstratesstrongcommand ofplanning and executingCMCprograms toguide teams toward phase-appropriate risk-based technical approaches.

• Recognizesas a go-to partner forscenario planning ofcomplex CMC topicsand understandsimpacts/trade-offsof technical changes across CMC disciplines.

• Helpsteams converge on scientifically defensible paths under uncertaintyin preparation forgovernance decision making.

• Anticipates downstreamclinicalregulatoryand manufacturability implicationsrelativeto the CMC strategy.

• Program/Project Management Expertise

• Leads complex technical decision-making by applyingsystemsthinking risk-based planning and scenario analysis. Anticipates ambiguity andstructureswork tomaintainmomentum and optionality.Observable behaviors:

• Proactivelyidentifiescross-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 AOPBvA) company business statements NPV and ROI calculations and applies to projects. Understands competitive landscape customerneedsand industry trends in context of projects/programs.

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

• Influenceshow departments across the companycollaborateto 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 andobjectives.

• Overseesend-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 committedtimeframesand budget

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

• Builds and synthesizeshighly-detailedproject plans budgeting & forecastingmodelsor 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 leadsmotivatesand inspires the internal and external resourcesto effectively deliver the program. Establishes the programs governance (e.g. sponsors approvers stakeholders)

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

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

• Proactively craftsfeasiblesolutions to combat risks and issues. Exercises sound judgement balancing risks and making prompt decisions in ambiguous ordifficult 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 andpromotesadoption 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;recommendsimprovements and changes as necessary

• Evaluates program costs and benefits including actual results and forecasts with comparisons to original or baselineplanand updates plans withaccurate up-to-date informationin 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 whilemaintainingtimelines 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:

• Bachelors degree

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

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