Takeda Pharmaceutical Company Limited.
Boston, MA, United States
Biotech, Sciences, Manager
Jun 25, 2020
Oct 08, 2020
Are you looking for a patient-focused, innovative-driven company that will inspire you and support your career development? If so, be empowered to take charge of your future at Takeda.
The fast-growing Cell Therapies team at Takeda is seeking an experienced Translational Scientific Manager who is also an expert in genomics to drive the delivery of pipeline assets and platform/technical projects.
As a member of the Cell Product Clinical Translational team, this role will contribute directly to the development and management of clinical translational assays in the Cell Therapies team, to enable forward and reverse translation to the clinic.
Success in this role depends heavily on strong scientific background, interpersonal skills, a keen attention to detail, a passion for project management and execution, technical
oversight of clinical biomarkers assay development and broad
knowledge in the IO and/or cell therapy preclinical and clinical translational space.
Works with project teams to determine which molecular genomics assays are needed for clinical trials and works with internal teams or CROs to develop these assays.
Coordinates with project teams and external vendors to determine which vendor will be used for genomics clinical assays (e.g.: ddPCR, RCR, RNAseq, DNAseq etc).
Oversees the testing of patient samples from Takeda’s clinical trials by external vendors.
Identifies and validates new technologies to better understand disease and patient response from patient samples.
The Genomics SME is an acknowledged subject matter expert in genomics and genomic bioassays who will oversee contracting, bioassay validations, logistical operations, sample processing and data generation for clinical studies supporting Takeda’s Cell Therapies.
Extensive knowledge of labwork and lab operations to ensure that the generated data meets required standards.
Knowledge about assay specific regulatory requirements.
Excellent scientific knowledge is critical for this role, exceptional collaborative and communication skills are also crucial.
The overall goal is to deliver high-quality clinical biomarker data to advance clinical programs to key decision points.
Serves as the genomics assay expert for Cell Therapy clinical programs.
Provide strategic, technical and scientific advice for development, implementation and data interpretation of an integrated clinical biomarker plan supporting proof of concept and decision making in assigned program(s).
Oversee required audits and validation to ensure bioassays are suitable for use.
Manage genomic biomarker assays for use in clinical trials.
Work with multiple Takeda functions to ensure biomarker assay needs for clinical development strategy are defined and technically delivered within the required clinical study timelines.
Work with Discovery scientists to translate preclinical biomarkers assay associated with mechanism of action and drug response into clinically useful assays.
Serve as the representative expert in genomics and genomic assays (PCR, NGS, RNA-Seq, Nanostring, etc).
Direct translation of preclinical assays into clinical use, providing expertise for clinical study start-up activities, including protocol writing and sample management plan documentation, and preparing data for teams within Takeda.
The Genomics SME will partner with preclinical scientists and clinical project teams to guide genomic assay selection.
Independently QC and analyse data from these platforms and serve as the link between informaticians and the biological questions which the clinical data is to answer.
Manage vendor labs to ensure timely delivery of high quality clinical data meeting clinical laboratory standards and regulatory requirements
Conduct technical on-site audits of vendor labs responsible for testing clinical biomarker samples.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Minimum B.S./M.S. 6+ years, or PhD with 2 years experience in biomarker assay design, development and clinical implementation
Excellent written and spoken communication skills are essential. The successful applicant needs to be able to exchange ideas in both technical and non-technical conversations as well as translate concepts between these two mediums.
Subject matter expert in genomic assays is required. These include but are not limited to ddPCR, RCR, and NGS.
Biological knowledge on Oncology and Immuno-Oncology is needed.
Superior analytical and problem-solving skills.
Exceptional organizational, interpersonal and time management skills.
Core lab, CRO or path lab experience preferred.
Experience with CAR-T, and gene therapies a plus.
An understanding of bioassay regulations such as CAP and CLIA are a plus
Experience working within a team-centric dynamic in an independent manner is a plus
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
No Phone Calls or Recruiters Please.
Takeda Pharmaceutical Company Limited.
Website : https://www.takeda.com