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 Biomarker Assay Scientist in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Scientist working on the Quantitative Translational Sciences team, you will be empowered to provide scientific expertise and work with stakeholders across multiple functions at Takeda, and a typical day will include the following.
- A Biomarker Assay Scientist is an acknowledged subject matter expert in several technology and patient characterization platforms such as flow cytometry and immunoassays, and whose primary role is to deliver high-quality clinical biomarker data for core therapeutic area programs in Immuno-Oncology/Oncology, Gastrointestinal, Neuroscience and Rare Diseases.
- Key areas of responsibilities include managing vendor labs responsible for the development and validation of clinical biomarker assays, and monitoring the performance of the biomarker assay during clinical study conduct. The Biomarker Assay Scientist is also responsible for ensuring contracts with vendor labs are fit-for-purpose and executed in a timely manner, supporting clinical study start-up activities including reviewing study lab manuals and associated documentation for biomarker assays. The Biomarker Assay Scientist will partner with various key stakeholders within the organization to provide scientific and technical expertise for the transfer, development and execution of clinical biomarker assays. The goal is to deliver high-quality clinical biomarker data to advance clinical programs to key decision points.
- The Biomarker Assay Scientist also must remain current and lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed.
- Given that biomarker assay development, validation and clinical sample analysis are externalized to vendor labs, manage the vendor labs to ensure timely delivery of high quality clinical data meeting clinical laboratory standards and regulatory requirements as applicable.
- 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).
- Collaborate with cross-functional groups within Takeda 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 assays associated with mechanism of action and drug response into clinically useful assays.
- Subject matter expert in the development and validation of flow and/or mass cytometry assays and immunoassay platforms such as ELISA and electrochemiluminescence (MSD).
- Conduct technical on-site visits of vendor labs responsible for testing clinical biomarker samples.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- B.S./M.S. with at least 5 years or PhD with at least 2 years of biomarker assay experience
- Subject matter expert in cytometry platforms such as flow and mass cytometry and/or immunoassays such as ELISA and electrochemiluminescence (MSD).
- Biological knowledge in a relevant scientific area, e.g., Immuno-oncology, Oncology, Immunology, Gastrointestinal, Biochemistry, Molecular Biology or Cell Biology is required.
- Pharmaceutical industry experience in translational and biomarker research preferred.
- Hands-on experience with clinical biomarker assay development and 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 from early to 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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.