Vertex Pharmaceuticals

Job Description

The Executive Director, Project Management and Strategic Operations is accountable for all activities and resources associated with the design and execution of all CMC Project Goals for Vertex’s Cell and Gene portfolio, including activities managed internally and with external partners. This role is responsible for providing strategic and integrated CMC cross-functional project leadership to deliver on the end-to-end Vertex disease and pipeline strategy. This includes leading high level portfolio oversight and CMC project management operations across the span of development - encompassing integration from preclinical research through registration. Additionally, the incumbent will also lead a high performing Project and Portfolio Management (PPM) function for the Biopharmaceutical Sciences - Cell and Gene Therapy.

This role will partner with the Biopharmaceutical Sciences CGT team on a variety of strategic, operational, and organizational matters across three pillars: CMC Project Leadership, Project Management and leadership team (LT) operations. This role will work closely with the SVP, Biopharmaceutical Sciences CGT to ensure alignment with strategic objectives.

Key Duties and Responsibilities:

• CMC Project Leadership:
• Partners with Biopharmaceutical Sciences LT members, and CMC PLs to ensure all projects have integrated CMC development plans, aligned with Disease Area Team’s strategic program goals and objectives
• Leads a team of dedicated CMC Project Leaders, each accountable for ensuring the integrated development and on schedule execution of one or more CMC Projects, partnering with the Process and Analytical Development, Manufacturing, Quality and CMC Regulatory Sciences
• Provides an enterprise perspective on assets/disease areas and strategy; creates alignment and strategic guidance in structuring and facilitating projects through drug discovery and development stage gates and effective governance
• Develops guidance and best practices for innovative program strategy that considers business landscapes
• Project Management
• Leads an effective Project Management function accountable to support effective project tracking, execution, and reporting with harmonized tools and systems
• Ensures PMs partner with CMC Project leaders to enable effective decision making
• Drives effective and streamlined process for scenario planning and option analysis for each project and overall portfolio
• Drives portfolio resource optimization through effective resource planning and forecast
• Enables integration between key cross-functional stakeholders to ensure alignment, operational efficiency and program success
• Partners directly with governance members and senior leaders to ensure preparation, implementation and follow-up of scientific and pipeline-related stage gates, decisions, and actions
• LT Operations
• Drives synchronization and harmonization of inputs, outputs and processes across governances and other pipeline related forums with a goal of streamlining and enhancing stakeholder experience associated with the pipeline governance and evaluation/management process
• Develops and manages a process for measuring and reporting progress on high-priority initiatives and programs across the organization
• Keeps SVP, CMC LT, and other senior executive stakeholders informed on key accomplishments, risks, and next steps
• Leads and/or manages special projects and high-profile initiatives, as appropriate
• Acts as a liaison between SVP and other company senior executives, to ensure alignment and coordination on a wide variety of cross-functional initiatives
• Supports SVP in defining and developing high-impact executive communications, including presentations for Executive Committee and Board of Directors meetings, as well as Town Hall meetings and other internal and external audiences
• Develops agendas and manages key leadership meetings to ensure that important decisions and action items are fully addressed

Knowledge and Skills:

• Expert, advance knowledge and experience in CMC Drug Development, namely for Cell & Gene Therapy, typically gained as Function or Department Head in CMC Development for Cell & Gene Therapy or Biologics modalities
• Strong biopharmaceutical drug discovery and development acumen across multiple disciplines
• Experience with both early and late-stage development programs
• Hands-on knowledge and experience and track record of success in CMC Regulatory requirements Cell & Gene Therapy, and Biologics (FDA, EMA, ICH, etc…)
• Expert, advanced knowledge of project and portfolio management principles, options analysis, strategic planning, business case generation, finance and resource management
• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources
• Excellent written and verbal communication skills, including well-developed presentation skills
• Organizational skills, an ability to manage multiple priorities
• Strong collaboration skills to effectively interact with internal or external stakeholders at all levels in the organization
• Advanced business management knowledge to assess the impact of project decisions on financial and corporate/enterprise objectives
• Proven ability to build and lead a high performing team
• Expertise and specialized knowledge in departmental business acumen
• Self-motivated -acts independently and prioritizes appropriately

Experience:

• Typically requires 15+ years of relevant work experience with 10+ years of management experience
• PhD degree in Bio/Chemical Engineering, Biology, Biochemistry or similar
• Experience in R&D environment in biopharmaceutical industry. Experience in start-up/fast-pace organizations
• Experience managing multiple complex and ambiguous task and assignments

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.