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Sr. Director, CMC

1 month, 1 week ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Allucent

Allucent

Allucent is a full-service Clinical Research Organization that specializes in providing high-quality solutions tailored to the unique challenges faced by small to mid-sized biotech firms in the development and approval of new therapies.

Pharmaceuticals
1K-5K
Founded 1994
View All Jobs 5

Description

  • Lead end-to-end CMC strategy across drug substance, drug product, and analytical development from early-stage evaluation through regulatory submission and commercial launch.
  • Author and review CMC submissions to support regulatory excellence and compliance.
  • Lead communications with Health Authorities and support interactions related to CMC matters.
  • Prepare product development plans spanning early development through Phase 4.
  • Manage direct reports, including development planning, performance management, and training on current and new regulatory requirements.
  • Provide scientific leadership on CMC and related pharmaceutical development activities for client programs.
  • Support development activities for drug, biologic, and medical device products.
  • Perform other related duties as needed.

Requirements

  • Bachelor’s degree, R.Ph., M.S., Ph.D., or equivalent in a scientific area.
  • Equivalent combination of relevant experience in drug, biologic, or device development.
  • Advanced scientific and regulatory knowledge of drug, biologic, or device development.
  • Experience in pre-approval products; large biologics experience is required.
  • Line management experience is required.
  • Prior CRO experience is preferred.
  • Strong critical thinking, analytical, and risk assessment skills.
  • Strong written and verbal communication skills in English, plus financial acumen and ability to influence and lead teams.
  • Strong computer skills, including SharePoint, Word, Excel, and PowerPoint.
  • >10 years of directly relevant post-degree experience in drug, biologic, or device development is desirable.

Benefits

  • Comprehensive benefits package, varying by location.
  • Competitive salary, varying by location.
  • Departmental study and training budget for professional development.
  • Flexible working hours within reason.
  • Remote or hybrid work opportunity depending on location.
  • Leadership and mentoring opportunities.
  • Participation in the Buddy Program for new or existing employees.
  • Internal growth opportunities and career progression.
  • Internal employee referral program with financial rewards.

Interested in this position?

Apply directly on the company website

Apply Now

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