Director, External Development & CDMO Partnerships

Alkermes; Boston (MA); Hybrid; USD 216,000 - 235,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus

Competitive benefits package

Job summary

Alkermes in Waltham, MA, is seeking a senior Pharmaceutical Development leader to drive CDMO oversight and development programmes through Stage 1 validation, with a transition to Technical Operations as programs progress toward Stage 2. The role emphasizes cross-functional collaboration across CMC, Clinical Supply, Quality, and Finance to align timelines and budgets.

Hybrid work is supported with 60% office time and onsite presence at least 3 days per week.

Qualifications

• Ph.D., M.S., or B.S. in a scientific or engineering discipline with 10+ years in pharma/biotech.
• Experience with clinical materials planning and CDMO oversight.
• Strong program and budget management capabilities.
• Ability to lead cross-functional teams in a matrix environment.

Responsibilities

• Lead development activities supporting program execution, including CDMO oversight.
• Serve as the primary contact with CDMOs to ensure on-time delivery.
• Manage CDMO timelines, deliverables, and KPI metrics.
• Schedule the Waltham manufacturing facility to align development and clinical supply.
• Coordinate governance reviews and periodic business/operational reviews.
• Collaborate with Legal on contracts and supplier agreements.

Skills

Communication skills

Project management

Cross-functional collaboration

Analytical skills

cGMP knowledge

Education

PhD/MS/BS in science or engineering

Job description

Alkermes in Waltham, MA, is seeking a senior Pharmaceutical Development leader to drive CDMO oversight and development programmes through Stage 1 validation, with a transition to Technical Operations as programs progress toward Stage 2. The role emphasizes cross-functional collaboration across CMC, Clinical Supply, Quality, and Finance to align timelines and budgets.

Hybrid work is supported with 60% office time and onsite presence at least 3 days per week.