Project Management & Strategic Operations Director

Vertex Inc.•Boston, MA

5d•Hybrid

About The Position

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.

Requirements

Some education, training or experience in biology/chemistry/engineering desirable
Drug Development knowledge and/or project management experience preferred
Proven experience in cross-functional execution including medium to large-scale projects
Critical thought partner and proven ability to connect people and ideas to drive outcomes
Demonstrated ability to connect with over divisions and functions throughout Vertex
Ability to manage multiple priorities/projects at a given time, ensuring deadlines, budgets and status updates
Highly developed communication skills and the ability to synthesize data and information into meaningful insights
Very detail oriented and strong project/operation management skills
Ability to handle ambiguity
Bachelor's degree
Typically requires 10 years of experience or the equivalent combination of education and experience

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 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