Project Management & Strategic Operations Associate Director

TL;DR

Project Management & Strategic Operations Associate Director (Preclinical/Regulatory): Integration, creation, and execution of multiple complex pharmaceutical development and regulatory plans with an accent on fully integrated project planning, cross-functional delivery, and budget/risk oversight. Focus on leading critical development projects, coordinating CRO deliverables, and supporting nonclinical regulatory submissions while mentoring teams and escalating issues to senior management.

Company

Vertex is a global biotechnology company investing in scientific innovation.

What you will do

• Establish project team operating norms, measure performance, and independently lead teams for critical development projects.
• Develop and maintain fully integrated project plans, including budgets, logistics, and scenario planning with assumptions, risks, and alternatives.
• Partner with CROs to schedule and report key preclinical deliverables; track high-level program deliverables and improve operational practices.
• Summarize program progress, timeline updates, and risk/opportunity assessments for periodic management presentations.
• Lead and support worldwide regulatory submissions from a nonclinical perspective and forecast/maintain program budgets, including oversight of direct reports.
• Mentor staff, resolve conflicts, and support goal-setting aligned with corporate objectives.

Requirements

• Bachelor’s degree.
• Typically 10 years of work experience (or equivalent combination of education and experience).
• Broad and comprehensive knowledge of GLP regulations.
• Comprehensive knowledge of pharmaceutical drug discovery and development across multiple preclinical disciplines (e.g., research, DMPK, toxicology, biomarkers).
• Extensive understanding of preclinical regulatory submissions documentation and process.
• Excellent written and oral communication skills; ability to influence decisions and outcomes across teams.

Culture & Benefits

• Hybrid-eligible role: choose Hybrid (remote up to two days per week) or On-Site (five days per week on-site with ad hoc flexibility).
• Annual bonus and annual equity awards; some roles may be eligible for overtime pay.
• Comprehensive benefits including medical, dental, and vision, generous paid time off (including a week-long company shutdown in Summer and Winter), and educational assistance.
• 401(k) and matching charitable donations, plus a generous commuting subsidy.

Hiring process

• Interviews with cross-functional stakeholders and senior management to assess project leadership, regulatory/preclinical expertise, and communication skills.
• Evaluation of experience with integrated project planning, CRO collaboration, and risk/budget management.

Location: Boston, MA

Salary: $155,700 - $233,500 (base range)