Senior Manager, Diagnostics and Biomarker Enrichment

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:

In this position, you will be part of the Diagnostic team, supporting Translational and Compound Development teams by providing evaluation, strategy, development, and implementation of biomarker enrichment/diagnostic tests in support of Genmab's portfolio.

You will be responsible for supporting the evaluation and implementation of biomarker and diagnostic strategies in collaboration with key stakeholders and ensure that the biomarker/diagnostic strategy is in alignment with the compound strategy and with timelines for clinical development of the therapeutic drug product. You will ensure the timely implementation of a biomarker enrichment/diagnostic strategy for the appropriate clinical programs while working in a highly matrixed environment across functional units within Genmab and external technology companies.

Responsibilities:

• Represent the Diagnostics Team on translational and/or compound development teams in enabling precision medicine, diagnostic and biomarker enrichment strategies
• Interact with Discovery, Translational, Clinical and Regulatory teams to understand the predictive hypotheses to be tested with the diagnostic-implementation strategy as needed for specific programs.
• Collaborate with internal research and cross-functional teams to test the pre-clinical/clinical utility of developed diagnostic assays and communicate timelines and capabilities of the development, validation, and implementation of a predictive biomarker/diagnostic assays.
• Work closely with translational research and biomarker operations team to select contract laboratory for development and/or utilization of diagnostic assays in early clinical development. Help oversee assay transfer to contract laboratory and ensure proper assay validation by working with subject matter experts within Genmab and the contract laboratory.
• In addition, this position is responsible for helping build, maintain, communicate, and coordinate processes for successful execution of Diagnostic development efforts at Genmab.
• Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents (e.g., IDEs, Performance evaluations, etc.) are delivered and communicate with regulatory authorities when required.
• Keep current with novel technologies that have impact on oncology diagnostic testing. Aid in selection of diagnostic assay methodologies. Help map marketplace on optimal technologies/platforms and use strategic considerations in choosing external partners.
• Establish and maintain collaborative relationships with external assay/platform vendors/KOLs/SMEs that can contribute to the compound development strategy.
• Provide internal and external subject matter expertise for precision medicine activities by acquiring and disseminating precision medicine knowledge to key stakeholders

Requirements

• MS or PhD in oncology (or related field) with 3-5 years of industry related experience in diagnostic/biomarker assay development, with thorough knowledge and experience in design control process, analytical and clinical validation, manufacturing, GCP, GLP, and GMP requirements
• Understand CLIA-laboratory, FDA, IVDR testing guidelines and assay validation requirements. Interactions with CDRH or other agencies in assay development is a plus
• Experience working in cross-functional teams and preferred experience with matrix leadership skills and ability to work effectively across multiple disciplines internal and external to the organization, with a track-record of having successfully managed diagnostic/biomarker assay development projects
• Broad knowledge and understanding of established and novel assay technologies (e.g., IHC, digital pathology, NGS, flow cytometry, liquid biopsy and MRD).
• Knowledge and understanding of the drug development process (clinical trials, efficacy endpoints, biomarker testing) is preferred
• Collaborative, positive, open, and objective mind-set with critical thinking skills.
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines
• Ability to be proactive, enthusiastic and goal oriented
• A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g., Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy
• Effective communication skills - both oral and written

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

$114,375.00---$190,625.00

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 bonuses.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 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 employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

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 https://www.genmab.com/privacy.

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.