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Here, you will be a vital contributor to our inspiring, bold mission.
Takeda is committed to outsmarting cancer so that more patients may have access to our transformational medicines – a robust precision and translational medicine approach thoughtfully and strategically applied in drug development is of essential importance to achieve this important objective of our Oncology drug development organization.
The Clinical Biomarker Sciences and Operations (CBSO) department at Takeda is seeking a strong scientific and operational leader in our clinical genomics efforts. The Associate Director, Genomics is an exciting, new role within the growing Precision & Translational Medicine (PTM) function in the Takeda Oncology Therapeutic Area Unit (OTAU) reporting to the Head of Genomics.
The individual recruited for this new role will serve as a resident genomic assay expert, whose role includes working within clinical study teams on effecting genomics-based biomarker assays/technologies into oncology Phase 1-3 clinical trials. The individual will identify and establish relationships with high quality external genomics partners, oversee assay implementation in clinical trials and QC data to support primary, secondary, and exploratory endpoints supporting Phase 1-3 clinical trials. The candidate will also lead the efforts for evaluating, piloting, and establishing innovative genomics technologies within PTM.
- Evaluate, select, and oversee high quality external genomic labs to ensure successful design and execution of clinical assays, including validation, longitudinal performance, and data quality.
- Oversee assays run under regulated approaches (GLP, GCP, GCLP, CAP/CLIA) and QC data to support primary, secondary and exploratory clinical trial endpoints.
- Review and approve genomics related components and interpretation of data in regulatory submissions (INDs, NDAs, BLAs, PMAs etc.).
- Attend and participate in key program team meetings (e.g., clinical, and translational sub teams) to provide insight and support for NGS, PCR, dPCR, RNA-seq, NanoString, single cell analysis, spatial transcriptomics and other genomic-based assays.
- Work closely with other scientists within CBSO Genomics function on development and implementation of fit-for-purpose assays for clinical and translational sub-teams.
- Collaborate with individuals from other functions including Computational Oncology to ensure fit-for-purpose data generation and assay development. Assist with data analysis and interpretation to inform program strategy and future clinical studies.
Education and Experience
- PhD degree in a scientific discipline with 7+ years experience , or MS with 13+ years experience, or BS with 15+ years experience
- 5+ years of Industry experience required
- 5+ years of managerial experience required
- Strong scientific background and experience with assay development and validation across technology platforms in genomics, especially those that are employed in clinical trials (e.g., NGS, WES, WGS, RNASeq, PCR, ddPCR and Nanostring).
- Experience with outsourcing and working with external academic and CRO partners to develop/transfer assays, oversee data generation/analysis and delivery of high-quality data from global clinical trials under regulated settings (GLP, GCP, GCLP and CAP/CLIA etc.).
- Familiarity with clinical documents and processes, such as clinical study protocols, informed consent forms, laboratory manuals, sample management forms, and data transfer agreements, etc.
- Strong written and oral communication skills
Ability to drive to or travel to conferences, partner meetings, laboratory audits as needed, including overnight trips. Some international travel may be required
Requires approximately 5 - 15% travel
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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.
Base Salary Range: $143,500.00 to $205,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Empowering Our People to Shine
Discover more at takedajobs.com
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Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
Boston, MAWorker Type