Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Sr. Genomics Scientist, Clinical Biomarker Innovation and Development, QTS, in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- Bioassay Scientist is an acknowledged subject matter expert in genomic biomarker assay and patient characterization platforms whose primary role is to design and implement clinical biomarker plans supporting the clinical biomarker strategy for core therapeutic area programs: Oncology, Rare Diseases, Gastrointestinal and Neuroscience.
- Responsibilities include directing translation of preclinical assays into clinical use, design and management of genomic assay validations at a vendor lab, supporting clinical study start-up activities including protocol writing and monitoring the performance of the clinical assay during clinical study conduct.
- The Bioassay Scientist will partner with DDU scientists and clinical project teams to identify biomarkers relevant to clinical application, providing scientific and strategic expertise to validate and implement clinical biomarker plans including technical feasibility, clinical context of use and regulatory requirements. This biomarker remit includes pharmacodynamics, patient characterization and selection. The goal is to deliver high-quality clinical biomarker data to advance clinical programs to key decision points.
- The Bioassay Scientist also must remain current and lead scientific due diligence to assess cutting-edge technologies and establish external partnerships to drive platform innovation.
- Manage external vendor labs for on time delivery of high quality genomics results for delivery to clinical teams.
- Provide strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated clinical biomarker plan supporting proof of concept and decision making in assigned program(s).
- Manage biomarker assays in phase I, II and III clinical trials
- Work with multiple Takeda functions to ensure biomarker assay needs for clinical
- development strategy are defined and technically delivered within the required clinical study timelines.
- Work with Discovery scientists to translate preclinical biomarkers assay associated with mechanism of action and drug response into clinically useful assays.
- Work with Computational scientists and statisticians to analyse and interpret data
- Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies.
- Subject matter expert in several technical platforms such as Quantitative PCR (qPCR), Next Generation Sequencing (NGS),, RNA Sequencing (RNA-Seq), Single Cell Sequencing ssNGS. Ability to independently QC and analyze data from assay results from these platforms.
- Given that clinical biomarkers are completely externalized to vendor labs, manage the vendor labs to ensure timely delivery of high quality clinical data meeting clinical laboratory standards and regulatory requirements
- Conduct technical on-site audits of vendor labs responsible for testing clinical biomarker samples.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Minimum B.S./M.S. with more than 5 years of experience in biomarker assay design, development and clinical implementation.
- Subject matter expert in several biomarker and patient characterization technologies required.
- Biological knowledge in a relevant area of biology, e.g., Oncology, Immunology, Neuroscience, Gastrointestinal, Biochemistry, Molecular Biology, Cell Biology required.
- Pharmaceutical industry experience in translational research and biomarker assay development preferred.
- Hands-on experience to carry out and manage outsourcing of assays to external vendor labs preferred.
- Capable of applying the highest scientific and technical standards for the successful design and execution of clinical biomarker assays implemented in early and late stage clinical programs.
- Superior analytical and problem-solving skills.
- Good communications skills, both oral and written.
- Exceptional organizational, interpersonal and time management skills.
- Experience working within a team-centric dynamic in an independent manner
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
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