Senior Director Of CMC And Nonclinical Program Management (Biotech)

TL;DR

Senior Director of CMC and Nonclinical Program Management (Biotech): Leading strategic planning and execution of development programs across CMC and nonclinical functions with an accent on cross-functional alignment, CDMO/CRO management, and regulatory compliance. Focus on driving complex drug development programs from discovery through commercialization while ensuring adherence to GxP standards and organizational goals.

Location: Must be based in North Dartmouth, MA (No sponsorship offered)

Salary: $223,814 - $279,767 USD

Company

hirify.global is a fully integrated, commercial-stage biotechnology company focused on developing treatments for central nervous system and immunology conditions.

What you will do

• Lead strategic planning and execution for CMC and nonclinical development programs.
• Manage relationships and performance with CDMOs and CROs to ensure project milestones are met.
• Oversee program budgets, timelines, and risk mitigation strategies across multiple development phases.
• Ensure regulatory compliance and quality standards (GMP, QbD) are maintained throughout the product lifecycle.
• Collaborate with internal technical teams and regulatory agencies to support IND, NDA, and BLA submissions.
• Provide leadership and mentorship to project management teams to foster accountability and high performance.

Requirements

• Must be authorized to work in the U.S. (No sponsorship provided)
• Bachelor’s degree in a relevant scientific discipline plus a Master’s or PhD.
• 15+ years of industry experience in biotechnology or pharmaceuticals as a CMC project team leader.
• Extensive expertise in CMC processes, GMP, and regulatory guidance (FDA, EMA, ICH).
• Proven experience managing complex programs through all development stages (Phase 1 through approval).
• Strong proficiency in project management tools and implementing GxP-compliant project management programs.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance plans.
• Retirement savings 401k with company match.
• Annual discretionary stock options.
• Generous paid time off, sick time, and paid holidays.
• Career development and training opportunities.