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Posted 22 Mar 2023
Billerica, Massachusetts - United States
Req Id 262444
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
- Accountable for evaluation and execution of Precision Medicine driven clinical genomics/NGS biomarker assays with specific focus on “fit for purpose” regulated clinical biomarker assay development, validation, transfer, implementation, sample testing for clinical development programs
- As part of the Global Clinical Biomarkers & Companion Diagnostics (CBD) , contribute to clinical biomarker & CDx testing and comprehensive data analysis: closely collaborate with colleagues from multiple departments including bioinformatics and biostatistics, medical lead , medical affair , BD, clinical operation, etc. to design and implement the data analysis plans, interpret biomarker and CDx results for clinical decision-making.
- Act as subject matter expert (SME) and provide support in Precision Medicine Focus clinical biomarker driven hypothesis testing & generation according to biomarker development plan(s). Candidate will oversee the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers)
- Conduct the Real world Clinical genomic data mining by working with bioinformatics, Biostat and Epidemiology group using different data sources.
- Working with global team to support the regional ( China, Japan , APAC ) clinical biomarker driven trials and/or global trials regional branch.
- Proactively works across project teams and partner lines (BD, Medical Affair etc. ) to conduct scientific & technical review of novel advanced biomarker technologies to build-up cutting edge biomarker/CDx capabilities
- Participate in preparation of clinical biomarker study plan linked to the clinical trial in close collaboration with CBD colleagues and other relevant functions.
- Contribute to preparation and update of biomarker prioritization lists in alignment with other relevant functions. Contribute to clinical genomics / NGS biomarker/ CDx content in submission documents.
- Contribute to review of clinical trial documents trial; including but not limited to LSD, LES, CTP, CTP amendments etc..
- Lead /co-lead the project related and advanced biomarker technologies focused external and internal scientific publication efforts .
- Prepare requests for information (RFI), requests for proposal (RFP), scope of work (SOW) and other relevant necessary documents for vendor qualification and support clinical outsourcing activities across project teams.
- Provide scientific and operational oversight of CROs and other ancillary vendors as appropriate to supervise CROs to achieve high standards of productivity and quality in supporting clinical BM/CDx outsourcing practice.
- Assist in development of CBD global outsourcing strategies. Contribute to establish & standardize outsourcing practices/tools to support clinical studies and ensure adherence to company’s strategy, policies, goals and procedures.
Who you are:
- Minimum of a Bachelor's degree in Genetics, Genomics, Biology, Immunology, Pharmacology, Biochemistry or other Science or Medical discipline
- 12+ years of experience in a Pharmacuetical or CRO setting
- Demonstrated “hands-on” experience in “fit for purpose” clinical biomarker assay development under regulated environment for clinical implementation using varieties of technologies (e.g. Clinical Genomics, RNAseq, NGS, , etc.)
- Expertise in clinical biomarker discovery and development, with advanced skills in biomarker assay design, development, troubleshooting, transfer, validation and sample analysis.
- In-depth understanding of scientific and operational requirement (considerations) in executing biomarker and/or CDx strategies in clinical development is required.
- Proven experience with reviewing of clinical trial related documents in candidate’s area of expertise (e.g. LSD, LES, CTP, CTP amendments).
- Proven abilities in managing outsourced clinical biomarker projects within quality, timeline, and budget expectations.
- Track record of publications in clinical/translational biomarker study as well as contribution/authorship in documents for regulatory submission.
- Oncology or immunology experience preferred
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html