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Associate Director, Diagnostics
4 months ago
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 Compound Development teams and Brand teams by providing evaluation, strategy, development, and implementation of diagnostic tests in support of Genmab’s clinical portfolio.
You will be responsible for end-to-end diagnostic strategy in collaboration with key stakeholders and ensure that the diagnostic strategy is in alignment with the compound strategy and with timelines for registration of the therapeutic drug product. You will ensure the timely implementation of diagnostic strategy for the appropriate clinical programs while working in a highly matrixed environment across functional units within Genmab and external Diagnostic companies.
**Responsibilities**:
- Represent Diagnostics Team on select translational research teams and compound development teams in enabling personalized healthcare for therapeutic programs- Collaborate with key stakeholders, including, but not limited to, Discovery, Translational Research, Clinical Research, Regulatory and Commercial teams to develop a diagnostic strategy to enable registration of a pharmaceutical asset alongside a diagnostic product.-
- Understand CLIA-laboratory, FDA testing guidelines and assay validation requirements.- Collaborate with Translational Research and with Clinical Research to design studies to test the clinical utility of the companion diagnostic.- Help to select the diagnostic partner to deliver potential companion diagnostic kit in time for pharmaceutical registration.- Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents (e.g. IDEs, PMAs, etc.) are delivered and communicate with regulatory authorities when required.- Regularly communicates updates to, and seeks feedback from, Clinical Teams, Compound Development Teams, and other stakeholders where appropriate, surrounding progress of the companion diagnostic program.- 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 a diagnostic partner.- Lead the development of single-plex/multiplex assays, including novel technologies, to support investigational and approved products in collaboration with diagnostic partners- Coordinate all executable activities between development teams and external diagnostic partners ensuring alignment of companion diagnostic development milestones with clinical milestones by developing/tracking timelines, budgets, and resources towards ensuring delivery of critical milestones from diagnostic partner and provides timely updates to relevant functional teams regarding development status**Requirements**:- At least five years of industry related experience in assay and IVD development, with excellent knowledge and understanding of design control process, analytical and clinical validation, manufacturing, GCP, GLP, and GMP requirements, US and global regulatory submissions (Pre-Subs, IDE, PMA), and commercialization of diagnostics- Proven experience working in teams and demonstrated 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 projects and success in working with multiple cross-functional teams.- Excellent knowledge and understanding of established and novel assay technologies (e.g., IHC, digital pathology, PCR, NGS, liquid biopsy, imaging).- Excellent knowledge and understanding of the drug development process (clinical trials, efficacy endpoints, biomarker testing)- 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 orientated- 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- Strong communication skills - both oral and written
$142,500.00-$237,500.00
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.
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