Scientist I- Immunoassay, Translational Biomarker Assay - United States
A Translational Biomarker Assay Lead Scientist is an acknowledged technical and strategic expert whose primary role is to design and execute on the biomarker assay strategy from Pre-Candidate Nomination (CN) through Proof of Concept (PoC) and Late Stage Clinical testing for core therapeutic areas: Oncology, Gastrointestinal and Central Nervous System. The Translational Biomarker Assay Lead Scientist works closely with the key stakeholders throughout the organization to ensure successful implementation of biomarker assays into clinical studies. Responsibilities include facilitating transfer of assays from Discovery to Translational and Biomarker Research, development of biomarker assays, designing and overseeing assay validations at a vendor lab, assisting with clinical study startup activities and monitoring the performance of the assay during clinical study conduct. These strategic goals include, for example, implementation of pharmacodynamic biomarkers indicating target engagement, safety and hypotheses for patient enrichment. The Translational Biomarker Assay Lead takes the lead in keeping up-to-date on, and providing scientific expertise regarding, cutting-edge technologies and establishing external partnerships, as needed, to deliver high-quality clinical biomarker data to advance clinical programs to key decision points.
- Work with Translational Lead Scientist, Translational and Biomarker Research Logistics group, Clinical Operations and Clinical Outsourcing to ensure biomarker assay needs for clinical development strategy are delivered within the required study timelines. Provides strategic, technical and scientific leadership for execution of these assays for assigned program(s).
- Work with Discovery scientists to design and execute the biomarker assay development strategy associated with mechanism of action and drug response.
- Independently develop, validate and implement biomarker assays in clinical trials and monitor the scientific quality of the assays during study conduct.
- Independently operate mesoscale discovery systems (MSD), Luminex instrument, microplate washers and microplate readers. Able to develop different types of immunoassays, including sandwich and competitive formats (ELISAs).
- Independently analyze immunoassay data, with interpretation of results and proposals for next steps.
- Able to present data in succinct fashion in various setting (lab meetings, team meetings, leadership meetings).
- Conduct technical on-site audits of vendor labs responsible for testing clinical biomarker samples.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- B.S./M.S. with 10+ years experience in relevant scientific area, e.g., Oncology, Immunology, Neurobiology, Endocrinology, Pharmacology, Biochemistry, Molecular Biology, Cell Biology.
- More than 5 years of relevant industry experience in translational research and assay development and validation.
- Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of translational biomarker assays implemented in early clinical programs in a timely manner.
- Hands-on experience developing immunoassay biomarker assays such as ELISA, Luminex and MSD is a must.
- Should serve as a “highly credible technical expert” to outside functional areas.
- Superior analytical, problem solving skills.
- Good communications skills, both oral and written.
- Exceptional analytical organizational, interpersonal and time management skills.
- Strong team play that thrives in a dynamic, “biotech-like’ environment.
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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