Project Management & Strategic Operations Director

Job Description

General Summary:

The Project Management & Strategic Operations Director - Clinical Development serves as the end-to-end program lead for large-scale strategic programs of high business value. Drives benefit achievement by leading program initiation, planning, solution design and build, and by measuring key performance indicators and solution adoption. Engages other colleagues/resources and assigns appropriate responsibilities to support achievement of program roadmap and project plan(s). Independently applies expert knowledge of advanced methodologies, selecting and applying high-level project management tools to conduct analyses, reporting and related activities for assigned projects. Contributes to the development of internal protocols and processes used to carry out program management work. Responsible for program management activities including contingency/dependency tracking, status reporting, issue/risk identification and tracking, scope management, estimation, and internal/external stakeholder management. Provides oversight to workstream/task leads within the program; resolves any escalated project risks, issues and dependencies. Manages the overall scope and timing of the program, ensuring on-time and within budget delivery.

This role will serve an important role in the Global Clinical Development organization to improve focus and alignment across programs and ensure greater organizational effectiveness. Responsibilities will include working with other functions within Vertex to obtain accurate, up-to-date plans and metrics across all clinical development programs to ensure visibility and alignment, including study milestones, enrollment metrics and budgets.

Key Duties and Responsibilities:

• Organizing, driving and managing the Clinical Development deliverables in terms of timelines, budget and communication.
• Serve as a strategic partner to the SVP, Clinical Development; create and run reports, create presentations, draft communications documents, serve on cross-functional strategic initiatives representing Clinical Development.
• Support the SVP, Clinical Development in creating, communicating and tracking annual goals
• Partner with Clinical Development Execution group to use the clinical operations systems to track study enrollment across programs vs target and translate the information to make it relevant and user friendly for Clinical Development.
• Work with finance, clinical development execution team and medical directors to track study budgets across programs vs target
• Collaborate with regulatory team to use the regulatory systems to track upcoming regulatory meetings and briefing documents (drafts/review schedule etc) and translate to make this information to make it relevant and user friendly for Clinical Development
• Run the TA review meetings including meeting minutes, tracking and archiving submissions and decisions
• Drive executional excellence in terms of timelines, sign-offs, submissions to internal governance (eg protocols, CSRs, etc) and external postings like clinical trials.org
• Support onboarding, compliance/SOP training and tracking, team effectiveness
• Lead communications within the Clinical Development team including updates within the team, to cross-functional partners including those ex-US, and bring relevant communications from the broader organization in to ensure the Development area are aware and prepared
• 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 an