Senior Director, Regulatory Submission Management (Boston, MA)

Job Description

General Summary:

The Senior Director, Regulatory Submission Management champions functional and cross-functional project and submission management excellence. The incumbent is expected to apply deep subject matter expertise in project and submission management to lead and identify opportunities, shape objectives and drive execution of key functional and corporate objectives. This role will be responsible for driving timeline risk mitigation and contingency planning.

Key Duties and Responsibilities:

• Provide strategic and operational project, submission and program leadership activities at all stages of the lifecycle (initiation through closeout).
• Drive communication cross-functionally and with senior leaders on project, submission and program planning topics including timelines, status, risks and issues.
• Proactively identify roadblocks and/or constraints impacting strategic imperatives or project execution and lead the team through scenario planning activities.
• Partner with governance forums, senior leaders and/or team lead(s) to align strategy, goals and milestones with corporate objectives.
• Propose innovative approaches, define process improvements and advise leaders on opportunities to optimize project results.
• Determine approach and stakeholders for cross-functional decision-making and issue resolution.
• Establish project team operating norms and measure performance.
• Leads and guides the team to efficiently identify and resolve unusually complex project issues within the team and drive the resolution to completion.
• Guides the team to prepare necessary reports to drive data-driven resource, budget and trade-off discussions across GRA function for complex programs.
• Identifies resource needs and resources in a scalable fashion utilizing and implementing outsourced models.

Knowledge and Skills:

• Advanced knowledge of project and portfolio management principles, options analysis, strategic planning, business case generation, finance and resource management.
• Experience in implementing and utilizing various outsourcing and support models
• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources.
• Excellent written and oral communication skills, including well-developed presentation skills.
• Organizational skills, ability to manage multiple priorities.
• Strong collaboration skills to effectively interact with internal or external stakeholders at all levels in the organization.
• General business management knowledge to assess the impact of project decisions on financial and corporate objectives.
• Expertise in global regulatory filing project management.
• Expertise in Global HA submissions and requirements and guidelines.
• Expertise in supervisory/management ability and experience.
• Ability to drive firm deadlines.

Education and Experience:

• Typically requires a Bachelor's degree in Life Sciences or a relevant field
• Typically requires 12 years of experience or the equivalent combination of education and experience
• Experience within the Life Sciences industry or similar

#LI-EE1 #LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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