Posted to MedZilla on 6/25/2018


Takeda Pharmaceuticals

US-MA, Sr Research Associate/ Scientist I Clinical Biomarker Assay Development R0001861-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Research Associate in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Research Associate/Scientist I working on the Translational Biomarker Research team, you will be empowered to provide your technical expertise with flow cytometry and immunoassays and successfully manage our vendors, and a typical day will include:

A Translational and Biomarker Assay Research Associate/ Scientist I is an acknowledged subject matter expert in several technology and patient characterization platforms including flow cytometry and immunoassays and whose primary role is vendor management. Responsibilities include directing translation of preclinical assays into a clinically feasible format and overseeing the development, validation and execution of clinical biomarker assays at vendor labs supporting clinical strategy for core therapeutic area programs: Oncology, Gastrointestinal and Neuroscience. The Translational and Biomarker Assay Scientist is also responsible for executing contracts with vendor labs, supporting clinical study start-up activities including reviewing study lab manuals and associated documentation and monitoring the performance of the biomarker assay during clinical study conduct. The Translational and Biomarker Assay Scientist will partner with Discovery scientists, Translational and Biomarker Scientific leads, Translational and Biomarker Operations group and clinical project teams to provide scientific and technical expertise for the development and execution of clinical biomarker assays. This biomarker remit includes target engagement, pharmacodynamic and patient selection. The goal is to deliver high-quality clinical biomarker data to advance clinical programs to key decision points. The Translational and Biomarker Assay Scientist also must remain current and lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed.

ACCOUNTABILITIES:

  • Given that biomarker assay development and validation 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.
  • Provide technical and scientific leadership for development, validation and implementation of clinical biomarker assays supporting proof of concept and decision making in assigned program(s).
  • Work with multiple Takeda functions to ensure biomarker assay needs for clinical development strategy are delivered within the required clinical study timelines.
  • Work with Discovery scientists to translate preclinical biomarker assay associated with mechanism of action and drug response into clinically useful assays.
  • Subject matter expert in several technical platforms including flow cytometry and immunoassays such as ELISA and electrochemiluminescence (MSD).
  • Ability to independently QC and analyze data from assay results from these platforms.
  • Conduct technical on-site visits of vendor labs responsible for testing clinical biomarker samples.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Minimum B.S./M.S. with 3-5 years or PhD with 1-2 years of experience in biomarker assay design, development, validation and clinical implementation.
  • Subject matter expert in flow cytometry and/or immunoassays such as ELISA and electrochemiluminescence (MSD).
  • Biological knowledge in a relevant scientific area, e.g., Oncology, Immunology, Neuroscience, Gastrointestinal, Biochemistry, Molecular Biology or Cell Biology is required.
  • Pharmaceutical industry experience in translational research and biomarker assay development preferred.
  • Hands-on experience with clinical biomarker assay development/validation to carry out 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

TRAVEL REQUIREMENTS:

  • 5-10% primarily US

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

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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