Onsite
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Objective / Purpose:
Enterprise level partner responsible for planning, coordinating, and overseeing all logistical activities required to manage the lifecycle of bioanalytical and biomarker samples in support of Takeda clinical studies. The incumbent will work cross-functionally with stakeholders in translational teams, therapeutic areas, clinical operations, and clinical data management to support end-to-end clinical sample, and sample metadata, management. The role also involves working with central laboratories, testing labs and long-term storage partners so that samples and sample metadata are tracked, are of the highest quality, and that chain-of-custody is maintained, allowing generation of high quality bioanalytical and biomarker data in support of Takeda clinical studies.
The position requires working in close partnership across various Takeda functions including Translational Sciences, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance to build effective and strategic relationships.
Coordinate the bioanalytical and biomarker specimen strategy within multiple clinical programs observing the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/GLP.
Work with study teams to develop clinical sample management plans, as well as review and contribute to clinical study protocols, informed consents, and central laboratory documents to ensure quality and accuracy.
Ensure biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of clinical samples. Ensure standardization and harmonization of end-to-end biospecimen activities across clinical studies; maximize biomarker specimen accrual and quality.
Candidate should have a working knowledge of analytical methods and fit-for-purpose assay rigor (qualification, validation, etc.) requirements needed to support clinical study endpoints.
Support the planning and coordination of clinical sample activities required to manage the lifecycle of biospecimen samples (e.g., collection, shipping, processing, analysis, and final sample disposition).
Support teams with biomarker sample tracking and management at the study level, in close collaboration with the Translational Team, Clinical Study Team, CRO and Central Laboratory.
Plan, coordinate, and oversee all logistical activities required to manage the lifecycle of bioanalytical and biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation with manual or automated processes, and final sample disposition).
Be familiar and coordinate end-of-study sample fate decisions, including consent and translational value considerations.
Work with vendors and partners for effective management of samples at central labs, testing labs and long-term storage facilities. Be familiar with assays and processes that support high quality samples throughout the sample lifecycle including inventory management. Be familiar with generating reports for sample tracking and reconciliation purposes.
Develops SOPs, job aids, flow charts, and other relevant educational materials, for effective training, education and advertising of Sample Management-related processes. Maintains Sample Management-related spreadsheets, trackers and forms.
Experience with managing FSP resources and leading small teams.
Experience with contracts/MSA/SOWs/MTAs reviews and submissions, and budget and financial systems relevant for the sample and sample metadata management role.
Education & Competencies
PhD degree in a scientific discipline with 3+ years experience , or MS with 9+ years experience, or BS with 11+ years experience.
Desired technical competencies:
Knowledge of drug development, clinical study principles and understanding of the role of bioanalysis and biomarkers in clinical studies.
Experience in sample (and sample metadata) management activities across multiple projects and phases of sample lifecycle.
Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling. Knowledge of regulations from other regions (e.g., China, EU CTR) a plus.
Experience with sample management platforms is a requirement.
Proven critical reasoning skills including the identification and resolution of complex problems.
Experience with leading small teams.
Ability to be an effective member of multi-disciplinary project teams.
Desired behavioral competencies:
Excellent written, organizational, leadership, and interpersonal communication skills necessary to interface with outside vendors and internal colleagues across diverse functional areas.
Works successfully under pressure and with tight timelines.
Self-motivated, highly independent, organized & detail-oriented.
This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
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.
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Want to know if this job is worth applying to?