Senior Director, Head of Department, CMC Late Stage & Development Project Management

Senior Director, Head of Department, CMC Late Stage & Development Project Management

Genmab

Copenhagen, Denmark

In this role, you will lead a growing team of 10 Project Managers and report directly to the Vice President, Late-Stage Manufacturing Development within Genmab Tech Ops (Denmark).

Responsibilities

• Provide day-to-day leadership of the LSMD Project Management team, including resource planning, recruitment, performance management, and capability development;
• Oversee CMC project strategy, timelines, and budgets across all LSMD-managed programs;
• Lead strategic project management initiatives, including ownership and continuous improvement of the LSMD Project Manual Contribute to LSMD strategic planning and ensure alignment across LSMD and the wider Tech Ops organization;
• Ensure compliance with relevant regulatory guidelines and industry standards;
• Support the maintenance and ongoing improvement of the CMC Operations quality system;
• Collaborate cross-functionally with internal and external CMC stakeholders to drive integrated product development strategies.

Requirements

• Master’s degree or higher in natural sciences, pharmacy, engineering, or a related field;
• Minimum 10–15 years of CMC experience within the pharmaceutical or biotechnology industry;
• Demonstrated project management experience within a CMC or development environment;
• Strong knowledge of global CMC regulatory requirements (e.g., FDA, EMA, NMPA);
• Proven experience contributing to CMC sections of regulatory submissions and interacting with global health authorities;
• Prior people-management experience with a track record of developing and leading high-performing teams;
• Excellent written and verbal communication skills in English.

About You

• You are genuinely passionate about our purpose;
• You bring precision and excellence to all that you do;
• You believe in our rooted-in-science approach to problem-solving;
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds;
• You take pride in enabling the best work of others on the team;
• You can grapple with the unknown and be innovative;
• You have experience working in a fast-growing, dynamic company (or a strong desire to);
• You work hard and are not afraid to have a little fun while you do so!