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

At Genmab we are dedicated to building extranotordinary 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!

The Role

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.

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 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.

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.

The position reports to the Director Global Clinical Drug Supply Operations based in Copenhagen.

Responsibilities

• Lead a team of approximately five individual contributors providing guidance mentorship and support to ensure strong individual and team performance.
• Set clear operational standards and foster a collaborative high-performing culture.
• 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.
• Provide expertise and insight into operational planning and execution with an innovative and inspection-ready mindset.
• Drive and support trouble shooting and development of risk mitigation plans.
• 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.
• 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.
• Drive and participate in maintenance of SOPs for the Global Clinical Drug Supply area with focus on operational aspects.
• Define lead organize and execute cross functional projects driven by Global Clinical Drug Supply Operations team.
• Stakeholder engagement and collaboration related to drug supply operations e.g. GMP QA and CMOs/vendors for packaging labelling and distribution.
• Contribute to maintenance of CMO landscape and outsourcing strategy for Global Clinical Drug Supply Operations including acting as Vendor Relationship Manager of selected CMOs.
• Have an oversight of country specific regulations for using trial supplies and ensure compliance and implementation of new regulations.
• Supervise train and educate colleagues in Global Clinical Drug Supply Operations.
• Set standards for operational work and compliance and support overall strategic direction and development in department.
• Responsible to be compliant with Genmabs quality system.

Requirements

• 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.
• Proficient in leading a team and your leader.
• Proven ability to balance dual responsibilities; leading a team while delivering as an individual contributor on complex projects.
• Extensive knowledge and understanding of GMP GDP and GCP.
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
• A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support global clinical trial supply strategy.
• Strong communication skills in English - both oral and written.

The Team

You will be part of a highly competent team focused on packaging and labelling of supplies for clinical trials working closely with the Global Clinical Drug Supply Planning team and our CMOs.

Together with Global Clinical Drug Supply Systems team and Strategy and Business Effectiveness team the four teams make up the Global Clinical Drug Supply department.

We have an international and informal working environment with a high pace while having fun and focus on one team spirit both within and outside the team and department.

Application

Has this sparked your interest Then we encourage you to upload your CV and cover letter including your motivation for this position. We screen candidates on a continuous basis and call in for interviews.

Fully remote applicants will not be considered so please indicate if you are willing to relocate if youre not currently living in commute distance.

For US based candidates the proposed salary band for this position is as follows:

The actual salary offer will carefully consider a wide range of factors including your skills qualifications experience and location. Also certain positions are eligible for additional forms of compensation such as discretionary bonuses and long-term incentives.

When you join Genmab youre joining a culture that supports your physical financial social and emotional wellness. Within the first year regular full-time U.S. employees are eligible for:

• 401(k) Plan: 100% match on the first 6% of contributions

• Health Benefits: Two medical plan options (including HDHP with HSA) dental and vision insurance

• Voluntary Plans: Critical illness accident and hospital indemnity insurance

• Time Off: Paid vacation sick leave holidays and 12 weeks of discretionary paid parental leave

• Support Resources: Access to child and adult backup care family support programs financial wellness tools and emotional well-being support

• Additional Perks: Commuter benefits tuition reimbursement and a Lifestyle Spending Account for wellness and personal expenses

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 maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

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 proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year if the employee performs well and if the business conditions do not change renewal for an indefinite term may be considered after the fixed-term employment contract.