Associate Director, Team Lead, Global Clinical Drug Supply - Operations

<p>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.</p><p></p><p>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.</p><p></p><p>Does this inspire you and feel like a fit? Then we would love to have you join us!</p><p></p><p></p><p><b><span>The Role</span></b></p><p><span>Genmab is searching for an experienced and energized Associate Director, Team Lead to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement.</span></p><p></p><p><span>This dual role combines leadership and individual contribution. You will lead and coach a team of approximately four to five individual contributors while also taking direct responsibility for selected early/late-phase clinical assets. In this capacity, you define strategic operational plans to ensure timely execution and provide oversight of packaging and labelling operations, ensure robust distribution setup, and drive innovative packaging solutions and processes in close collaboration with CMOs.</span></p><p></p><p><span>The role offers a unique opportunity to shape supply chain strategy, optimize late-phase trial delivery, and play an active part in bringing transformative medicines to patients.</span></p><p></p><p><span>The position reports to the Director, Global Clinical Drug Supply Operations based in Copenhagen.</span></p><p></p><p><b><span>Responsibilities</span></b></p><p></p><ul><li>Lead a team of approximately five individual contributors providing guidance, mentorship and support to ensure strong individual and team performance.</li><li>Set clear operational standards and foster a collaborative, high-performing culture.</li><li>Act as an individual contributor with direct responsibilities for early- and late-stage clinical assets including development, implementation and maintenance of strategic plans and provide oversight across packaging and distribution setup.</li><li>Provide expertise and insight into operational planning and execution with an innovative and inspection-ready mindset.</li><li>Drive and support trouble shooting and development of risk mitigation plans.</li><li>Define, lead, organize, and execute inspection activities e.g. related to submissions to EMA, FDA and PMDA as well as other periodic inspections and audits.</li><li>Drive and contribute to implementation activities related to Global Clinical Drug Supply strategies and build of capabilities operationally in collaboration with Global Clinical Drug Supply Planning and Systems teams.</li><li>Drive and participate in maintenance of SOPs for the Global Clinical Drug Supply area with focus on operational aspects.</li><li>Define, lead, organize, and execute cross functional projects driven by Global Clinical Drug Supply Operations team.</li><li>Stakeholder engagement and collaboration related to drug supply operations e.g., GMP QA and CMOs/vendors for packaging, labelling and distribution.</li><li>Contribute to maintenance of CMO landscape and outsourcing strategy for Global Clinical Drug Supply Operations including acting as Vendor Relationship Manager of selected CMOs.</li><li>Have an oversight of country specific regulations for using trial supplies and ensure compliance and implementation of new regulations.</li><li>Supervise, train, and educate colleagues in Global Clinical Drug Supply Operations.</li><li>Set standards for operational work and compliance and support overall strategic direction and development in department.</li><li><span>Responsible to be compliant with Genmab´s quality system.</span></li></ul><p></p><p><b><span>Requirements</span></b></p><ul><li><span>6+ years’ experience in handling clinical drug supply, including setting up label text, handling of ancillaries, distribution with cold chain management from CMO, Biotech or Pharma companies.</span></li><li><span>Proficient in leading a team and your leader.</span></li><li><span>Proven ability to balance dual responsibilities; leading a team while delivering as an individual contributor on complex projects.</span></li><li><span>Extensive knowledge and understanding of GMP, GDP, and GCP.</span></li><li>Ability to work successfully under pressure in a fast-paced environment an