Senior Director, CMC Lifecycle & Portfolio Strategy

About the Role

Genmab is seeking a Senior Director, Head of Life Cycle Management (LCM) to join the CMC Project & Portfolio Management team within Technical Operations. In this newly established role, the Senior Director will be accountable for end-to-end CMC lifecycle management of Genmab’s global commercial products, ensuring supply continuity and regulatory compliance.

This is a unique opportunity for an experienced leader to shape Genmab’s CMC Life‑Cycle Management strategy and operations, and to develop the team driving this effort.

The position reports to the Vice President, CMC Project & Portfolio Management, based in Genmab Technical Operations, Denmark.

Key Responsibilities

• Accountable for Genmab’s CMC LCM operations and strategy across partnered and fully owned products, ensuring alignment with portfolio priorities, global expansion plans, and regulatory expectations
• Lead and develop the CMC LCM Team, including resource planning, recruitment, performance management, and capability building
• Own and manage product knowledge throughout the product lifecycle
• Lead lifecycle risk management strategies
• Define and drive global regulatory CMC lifecycle strategies
• Responsible for CMC lifecycle budgets and timelines
• Responsible for project management activities in support of manufacturing activities at global CMOs, including deviations, change management and release in collaboration with MSAT, Commercial QA and Commercial Supply Chain
• Lead Post‑Approval Change Management, including regulatory submission in collaboration with MSAT, Commercial QA, Regulatory CMC, CMC writing, and PD Development
• Coordinate technical and operational support for product‑specific roadmaps, e.g. line extensions, SKU expansion, dosage form modifications, or new market introductions, etc.
• Lead/Support initiatives to optimize yield, reduce cost of goods, and enhance robustness of manufacturing and testing processes
• Ensure CMC lifecycle activities remain compliant with current GxP standards and Health Authority expectations
• Collaborate with Regulatory Affairs, Commercial QA, CMC Late‑Stage Development, MSAT and Commercial Supply Chain to drive cross‑functional planning and execution

Requirements

• Advanced degree (MSc or PhD) in Pharmacy, Chemistry, Biotech, Engineering, or a related field
• 15+ years of experience in the biopharmaceutical industry, with a strong background in CMC, manufacturing, or technical operations
• Proven track record in commercial product lifecycle management, especially in a multi‑product, global supply setting
• In‑depth knowledge of post‑approval change management, regulatory filing strategies, and global compliance requirements
• Broad understanding of global cGMP requirements to support the continuous and uninterrupted supply of Genmab’s commercial drugs
• Strong leadership skills and demonstrated ability to lead cross‑functional teams and manage complex global projects
• Excellent communication skills and ability to interact effectively with senior stakeholders, both internally and externally
• Prior people‑management experience with a track record of developing and leading 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!

Locations

Genmab is headquartered in Copenhagen, Denmark, with an agile working environment that welcomes both in‑office and remote colleagues.