Senior Scientist, Clinical Biomarkers Oncology
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist, Clinical Biomarkers Oncology 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 the Senior Scientist, Clinical Biomarkers Oncology you will impact the clinical development and approval/post-approval of novel therapeutics and modalities, as well as CDx development, with a strong focus in solid tumors. In this role, you will contribute to Takeda's mission by contributing to translation plans and bringing Takeda's pipeline to the clinic. A typical day will include:
The Clinical Biomarker Innovation & Development department at Takeda is seeking a strong scientific leader to join its Oncology group. The candidate will impact the clinical development and approval/post-approval of novel therapeutics and modalities (small molecules, antibodies, nucleic acid, & gene therapies) across all therapeutic areas with a strong focus in solid tumors.
Propose and establish experimental plans for developing and outsourcing clinical biomarker assays for both retrospective and prospective analyses (e.g. companion diagnostics) according to the project timelines, coordinate various outsourcing activities, analyze resulting biomarker data, and provide regular updates to the stakeholders.
Drive the adaptation, execution, and integration of cutting-edge tissue and blood-based assay technologies, including IHC, multiplex IF/IHC, FISH, flow cytometry, immunoassays, and NGS. Experience with minimal residual disease (MRD) assays and oncology-based gene panels is a plus.
Develop and leverage new technologies that can significantly impact clinical drug development decisions.
Remain current and lead scientific due diligence to assess emerging technologies and establish external partnerships as needed, as well as, actively publishing in the scientific community external to Takeda.
Contribute to Translational, Biomarker, and Clinical plans and assisting in the development and implementation of clinical biomarker strategies by interfacing between DDU scientists and TAU clinicians; represent CBID at internal scientific meetings and external forums.
Subject matter expert in the development and validation of clinical grade assays, as well as, exploratory assays using various advanced technologies that may not be currently in clinical use.
Perform evaluation and selection of adequate technologies for establishment of clinical biomarker assays which meet clinical laboratory standards and regulatory requirements.
Provide technical and scientific leadership throughout different phases of assay development and validation.
Manage vendor labs responsible for the development and validation of clinical biomarker assays and monitor the performance of the biomarker assay during clinical study.
Lead the establishment and development of CDx platforms by managing external vendors for timely delivery of high-quality clinical data within the required clinical study timelines.
Collaborate with computational scientists and statisticians to perform data mining and interpretation, present the data in project team meetings.
Build relationships and collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
A PhD or MD/PhD in biology, pharmacology, or related discipline with at least 4 years of experience past post-doctoral experience is required.
Drug development experience preferably advancing several molecules from Phase I to approval and supporting post-marketing/commercial activities.
A track record of sustained, significant scientific contributions as demonstrated by publications, patents, and presentation is required.
Strong scientific background and experience with assay development and validation as well as complex image and data analysis.
Experience with clinical trial and/or patient samples.
Capable of applying the highest scientific and technical standards for the successful design and execution of clinical assays implemented from early to late-stage clinical programs.
Strong communication and collaborative skills, ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments.
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Takeda Pharmaceutical Company Ltd