Project Management & Strategic Operations Associate Director

Associate Director, Preclinical Sciences, Program Management and Strategic Operations

The Associate Director, Preclinical Sciences, Program Management and Strategic Operations will be responsible for integrating, creating, and executing multiple complex pharmaceutical development/regulatory plans. By collaborating closely with Project Leaders, cross‑functional Project Team members, and contract research partners, the incumbent develops and maintains fully integrated project plans to ensure deliverables are successfully executed, meet project and disease‑area objectives, and remain within budget.

The incumbent is also responsible for comprehensive communication, including status reporting, risk management, and escalation of issues to cross‑functional stakeholders and Senior Management.

• Establish project team operating norms and measure performance.
• Lead teams for critical development projects independently.
• Review and compile developed plans, budgets, and logistics; assist in scenario planning to provide alternate development plans with associated assumptions and risks.
• Work directly with Contract Research Organization (CRO) partners on scheduling and reporting of important preclinical deliverables.
• Summarize key information such as program progress, timeline updates, and risk/opportunity assessments for periodic presentations to management.
• Track all high‑level program deliverables and seek innovative ways to stay abreast of multi‑dimensional tasks.
• Lead and support worldwide regulatory submissions from a nonclinical perspective.
• Forecast and maintain program budget, including oversight of programs of direct reports.
• Mentor staff on professional and ethical development, motivate personnel, and resolve conflicts.
• Set goals for direct reports and ensure linkage to personal and corporate objectives.
• Apply subject‑matter expertise to mentor subordinate managers and high‑level professionals.
• Serve as study representative on preclinical studies.
• Manage one or more direct reports.

Bachelor’s Degree.

Typically requires 10 years of work experience or the 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, drug metabolism and pharmacokinetics, toxicology, biomarkers, etc.).
• Extensive understanding of preclinical regulatory submissions documentation and process.
• Excellent written and oral communication skills.
• Understanding of disciplines beyond own specialty area.
• Effective influence of decisions and outcomes across teams.

• Knowledge of or experience working in an outsourced preclinical model.
• Preclinical Regulatory experience in both IND/CTA and global marketing submissions.

$155,700 - $233,500. The role is eligible for an annual bonus and annual equity awards; some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

The role is eligible for a comprehensive benefits package that includes medical, dental and vision benefits, generous paid time off, educational assistance programs, commuting subsidy, charitable donation matching, 401(k) and more.

Hybrid‑Eligible or On‑Site Eligible:
Hybrid (up to two remote days per week) or On‑Site (five days per week with ad‑hoc flexibility). Flex status may be changed at any time per company policy.

Vertex is a global biotechnology company committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants. Vertex is an E‑Verify Employer in the United States and will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law. Vertex welcomes applicants who require accommodations during the hiring process or to perform essential job functions and encourages them to contact Talent Acquisition.

Vertex’s diversity and inclusive culture is an integral part of our success.