(Associate) Director, Companion Diagnostics Job at Genmab
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
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:
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Represent Diagnostics Team on select translational research teams and compound development teams in enabling personalized healthcare for therapeutic programs
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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.
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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.
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Understand CLIA-laboratory, FDA testing guidelines and assay validation requirements.
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Collaborate with Translational Research and with Clinical Research to design studies to test the clinical utility of the companion diagnostic.
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Help to select the diagnostic partner to deliver potential companion diagnostic kit in time for pharmaceutical registration.
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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.
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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.
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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.
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Lead the development of single-plex/multiplex assays, including novel technologies, to support investigational and approved products in collaboration with diagnostic partners
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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
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Provide internal and external subject matter expertise for precision medicine activities by acquiring and disseminating precision medicine knowledge to key stakeholders
Requirements
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PhD (preferred) in Life Science or equivalent M.S. degree will be considered for exceptional candidates
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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
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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.
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Excellent knowledge and understanding of established and novel assay technologies (e.g., IHC, digital pathology, PCR, NGS, liquid biopsy, imaging).
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Excellent knowledge and understanding of the drug development process (clinical trials, efficacy endpoints, biomarker testing)
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Collaborative, positive, open, and objective mind-set with critical thinking skills.
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Ability to work successfully under pressure in a fast-paced environment and with tight timelines
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Ability to be proactive, enthusiastic and goal orientated
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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
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Strong communication skills - both oral and written
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.
At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
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.
Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location 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.
Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website
https://www.genmab.com/privacy
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Scam alert
Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.
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