Biomarker Operations Manager

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!

The Role

The Biomarker Operations Manager will work in multidisciplinary international project teams to discover and develop antibody therapeutics. The Biomarker Operations Manager will manage the operations and logistics necessary to execute the scientific strategy for Oncology projects, contributing to the development of ground-breaking new medicines from concept to the market. The successful candidate will be responsible for working closely with the Director, Biomarker Operations, and all key stakeholders to ensure the Biomarker Operations function is an integral part of Genmab clinical studies moving forward.

Responsibilities

• Working with Clinical Management Teams (CMTs) and biomarker/translational research teams to implement and execute the clinical biomarker and translational sample strategy for projects
• Managing sample logistics and operations for clinical and biomarker samples, working closely with CMT team personnel, central laboratories, and specialty lab vendors
• Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition)
• Providing biomarker operational expertise and guidance to cross-functional and CMTs
• Proactively supporting the CMTs during data cleaning process to ensure oversight of biomarker samples, data transfer and reconciliation procedures
• Contributing to the assessment of site and lab feasibility for biomarker sample collection, handling, and storage
• Ensuring review of lab specifications and manuals as well as sample handling training and collection/processing materials for investigator sites/monitors together relevant internal and external stakeholders and the central lab
• Supporting presentations and trainings of sites and monitors as needed.

Requirements

• Bachelor's degree or equivalent and 3+ years of industry related experience
• Excellent knowledge and understanding of Oncology clinical trials and the role of biomarkers and translational medicine in clinical studies
• Extensive knowledge and understanding of clinical research, ICH, GCP, GLP, data management, regulatory and legal issues/processes as they relate to biomarker samples
• Proven experience working in teams managing oncology clinical studies within the pharmaceutical/CRO industry
• Extensive experience working with sample/biomarker logistics and operations
• Experience with SOPs, guidance and work instructions and ability to draft biomarker related documents or sections within these documents
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines
• Ability to be proactive, enthusiastic and goal orientated
• Strong communication skills - both oral and written

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

$105,040.00---$157,560.00

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, you're 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 you're 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, Genmab's 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 Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab's 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.