Associate Director, Nonclinical Development Program Management & Strategic Operations (Late-Stage Development)

Location: Boston, MA, United States. Hybrid work allows remote work up to two days per week, or the role can be performed on-site five days per week with ad hoc flexibility.

Salary: $155,700–$233,500 base salary per year, plus eligibility for an annual bonus and annual equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and pharmaceutical development.

What you will do

• Lead complex cross-functional nonclinical development programs from planning through execution, maintaining integrated project plans, budgets, forecasts, risks, and dependencies.
• Coordinate with Project Leaders, Regulatory Affairs, nonclinical subject matter experts, CROs, and external collaborators.
• Lead operational planning and execution for NDA/BLA marketing applications, IND/CTA applications, global submissions, supplements, amendments, and post-marketing commitments.
• Coordinate authoring, review, approval, document readiness, health authority responses, and submission-related action tracking.
• Report program status, timelines, risks, mitigation strategies, and escalation items to project teams and senior leadership.
• Manage direct reports and support professional development, performance management, and goal setting.

Requirements

• Bachelor’s degree in a scientific discipline or related field.
• Typically 10+ years of relevant experience in the pharmaceutical, biotechnology, or life sciences industry, or an equivalent combination of education and experience.
• Experience managing nonclinical drug development programs and regulatory submissions across multiple development stages, including NDA/BLA activities.
• Broad knowledge of GLP regulations and nonclinical disciplines including toxicology, DMPK, biomarkers, and translational sciences.
• Experience coordinating cross-functional regulatory authoring, review, approval, delivery, submission readiness, and complex timelines.
• Strong communication, organization, planning, problem-solving, influence, and risk management skills.

Nice to have

• Late-stage development and filing experience, including post-approval regulatory activities and health authority responses.
• Experience with FDA, EMA, MHRA, PMDA, and other international health authorities.
• Experience working in an outsourced nonclinical development model and using project management tools.

Culture & Benefits

• Hybrid or on-site work options under the Flex @ Vertex program.
• Medical, dental, and vision benefits with paid time off and company shutdown periods in summer and winter.
• Educational assistance, including student loan repayment support.
• Commuting subsidy, matching charitable donations, 401(k), and other total rewards.
• Continuous learning opportunities focused on AI, technology, automation, and industry developments.