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 p recision 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 assay s and communicate timelines and capabilities of the develop ment , validat ion , and implement ation of a predictive biomarker/diagnostic assay s .
Work closely with translational research and biomarker operations team to select contract laboratory for de velopment 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 partner s .
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 d iagnostic /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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity