9 days old

Principal Scientist / Associate Director Clinical Biomarkers - Gastroenterology

Millennium Pharmaceuticals, Inc.
Boston, MA 02109
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Job Description

Principal Scientist / Associate Director Clinical Biomarkers - Gastroenterology

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Scientist / Associate Director Clinical Biomarkers Gastroenterology 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 deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Principal Scientist / Associate Director Clinical Biomarkers - Gastroenterology working on the Clinical Biomarkers team, you will be empowered to contribute to the clinical development of novel therapeutics in Gastrointestinal area from pre-IND to Phase I-III clinical trials. A typical day will include:


  • Contribute to the clinical development of novel therapeutics in Gastrointestinal area from pre-IND to Phase I-III clinical trials through developing and executing translational/clinical biomarker strategies. Strong focus in gut microbiome, cell therapy is a plus
  • Provide technical and scientific leadership as the CBID program lead, harmonize the activities within CBID, and collaborate with larger program/clinical team to assure the clinical biomarker assay and data delivery
  • Conduct biomarker assay development across different technologies and disease area within GI, including cutting edge technology assessment, applying validation process to meet fit-for-purpose assay development, understanding and troubleshooting the technical, regulatory and logistic aspects


  • Attend and participate in the key program team meetings (clinical and translational sub-teams), communicate the key activities, deliverables and timelines updates to the CBID team
  • Lead CBID team and organize CBID sub-team meeting to harmonize the activities to support the program.
  • Contribute to the development and implementation of clinical biomarker strategies by interfacing between GI DDU scientists and GI TAU clinicians; represent CBID at internal scientific meetings and external forums
  • Review and ensure alignment of clinical documents with the biomarker plan, e.g. clinical protocol, Informed Consent Form and contribute to Laboratory Manual, Investigators Brochure, etc as needed.
  • Initiate technology/vendor selection, plan fit-for-purpose assay validation, oversee and review the validation process and report to ensure that the report meets regulatory requirement
  • Manage vendor labs responsible for the development and validation of clinical biomarker assays and monitor the performance of the biomarker assay during clinical study conduct.
  • Conduct sample management plan
  • Collaborate with clinical operations and CRO labs to ensure the high quality data delivery
  • Collaborate with computational scientists and statisticians to perform data mining and interpretation
  • Lead the establishment and development of CDx platform by managing external vendors for timely delivery of high-quality clinical data within the required clinical study timelines when applicable
  • Develop/build upon disease-based knowledge for key indications of interest in GI, i.e. biology of disease, clinical treatment paradigms, current competitive landscape, and current/emerging biomarkers.
  • Build relationships and collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities.
  • Success in this role will be evaluated by the ability to influence and inspire scientists in the organization, and to maintain a culture that encourages innovation, scientific rigor, and collaboration.


  • A PhD, MD, or MD/PhD in biology, pharmacology, or related discipline with at least 8 years of post-doctoral experience, including at least 3 years in the drug development in industry is required.
  • Strong knowledge and experience in microbiome, especially identification/detection of microbiome and data analysis
  • Strong understanding and experience in drug development, especially designing and strategize clinical biomarker in early clinical development
  • A track record of sustained, significant scientific contributions as demonstrated by publications, patents, and presentations is required.
  • Strong scientific background and experience with assay development and validation in multiple technology platforms, especially those that are implementable in clinical study.
  • Experience with clinical trial and/or patient samples, especially with in gastroenterology is strongly desired.

This job posting exclude Colorado applicants.


  • 5 10% US based


  • 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

Discover more at takedajobs.com

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Boston, MA

San Diego, CA

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Full time

Posted: 2021-06-07 Expires: 2021-07-06
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Principal Scientist / Associate Director Clinical Biomarkers - Gastroenterology

Millennium Pharmaceuticals, Inc.
Boston, MA 02109

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