Associate Director, Diagnostics Genmab On-site Princeton
1 week ago
At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering 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.
- Interact with Translational Research teams to understand the predictive hypotheses to be tested for specific programs. Collaborate with internal research capabilities to develop, validate, and implement a predictive assay if not already available. Working closely with translational research and biomarker operations team to select contract laboratory for testing predictive assays in early clinical development. Help oversee assay transfer to contract laboratory and ensure proper assay validation by working with subject matter experts within the department.
- 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 communicate updates to, and seek 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.
- Provide internal and external subject matter expertise for precision medicine activities by acquiring and disseminating precision medicine knowledge to key stakeholders.
Requirements:
- PhD (preferred) in Life Science or equivalent M.S. degree will be considered for exceptional candidates.
- 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 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.
- Strong communication skills - both oral and written.
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.
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.
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