Director Team Lead Late Stage CMC Project Management

Job description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Role and Department The Late Stage CMC Project organization is growing and we are looking for 2 Directors to lead and develop a team of Project Managers in Genmab’s late-stage CMC project organization. The roles have similar responsibility and you will combine people leadership with strategic oversight and hands-on responsibility for complex CMC programs, including contribution to governance of outsourced activities with contract development and manufacturing organizations (CDMOs). Both postions report to the Senior Director, Head of the Late-Stage Project Management Office, within Genmab Tech Ops in Denmark. Working closely with CMC, Regulatory Affairs, Quality and Supply Chain, you will align CMC delivery with development priorities and drive progress towards regulatory submission and commercial readiness. You will help shape the late-stage project organization, develop experienced Project Managers and translate portfolio priorities into clear decisions and reliable delivery. Responsibilities Team leadership and development Lead and develop your team through resource planning, recruitment, performance management and succession planning, building capabilities for current and future portfolio needs Coach Project Managers in strategic thinking, cross-functional leadership and resolving complex CMC challenges. Set clear expectations, delegate effectively and build accountability for results Work closely with the Senior Director to prioritize resources and budgets across the team’s programs, resolve capacity constraints and align delivery with portfolio objectives CMC strategy and project responsibilit ies Shape CMC strategies with technical and functional leads, aligned with overall Drug Development Plans. Lead assigned programs through integrated planning, budget analysis and management of cross-program dependencies. Drive cross-functional delivery of technology transfer, process validation, manufacturing readiness and submission documentation, with clear ownership and adherence to Genmab’s quality system and applicable regulatory requirements Ensure reliable plans, risk and decision logs, and executive reporting. Anticipate portfolio impacts, resolve high-impact issues and facilitate data-driven options and recommendations to senior governance forums Lead improvements to the Project Manual, governance and ways of working, including digital and AI-enabled tools that strengthen planning, risk management and delivery CDMO collaboration and project governance Representing Late Stage CMC Project Management in CDMO joint project and steering committees, facilitating strategic discussions and decisions within delegated authority. Ensure decisions translate into clear commitments and follow-through Shape outsourcing and partnership strategies with relevant functions, aligning proposals, contracts and quality agreements with program objectives, business needs and intellectual property considerations Hold partners accountable for agreed scope, quality, timelines and budgets. Build transparent relationships, resolve vendor conflicts and escalate strategic trade-offs and risks with clear recommendations Requirements Master’s degree or higher in natural sciences, pharmacy, engineering or a related discipline, or equivalent experience Extensive biopharmaceutical CMC experience, including late-stage biologics development and progression towards commercial supply. Experience with antibody-drug conjugates is an advantage Proven experience shaping strategies and leading complex global CMC programs, including portfolio prioritization, strategic budget management and cross-functional risk resolution Established people-leadership experience, with a track record of developing Project Managers, building team capabilities and supporting talent and succession planning Strong understanding of technology transfer, process validation, submission strategies and the interdependencies between development, manufacturing and supply Experience shaping outsourcing strategies, leading CDMO governance and resolving complex partner issues with sound business judgment Advanced knowledge of GMP and global CMC regulatory expectations, including those relevant to FDA, EMA and NMPA submissions Excellent English communication skills, with a track record of influencing senior stakeholders and translating complex issues into clear business recommendations. About You You combine strategic perspective with the judgment to know when to engage directly and when to empower others. You develop people, set clear priorities and make well-founded decisions under uncertainty, balancing quality, timelines and cost. You build trust across functions and cultures, challenge assumptions constructively and create an inclusive environment where colleagues take ownership. You champion a ONE-Team approach, welcome feedback and turn lessons learned into improvements across the project organization. Location and Travel The role is based in Denmark. Travel is expected to be approximately 10–15 days per year. Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect our employees. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK883.200,00---1.324.800,00 The final salary offer will depend on several factors, including your skills, qualifications, and experience. In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to: Pension Health insurance and wellness benefits Paid time off Employee support programs Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a pro