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Director, Group Lead, Sample & Data Management

Boston, Massachusetts
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  • Job Level: Senior
  • Travel: Minimal (if any)

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

Job ID R0127135 Date posted 07/08/2024 Location Boston, Massachusetts

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Group Lead, Sample & Data Management in our Cambridge, MA location.

As Director, Group Lead, Sample & Data Management, you will be an enterprise level partner responsible for planning, coordinating, and overseeing all logistical activities required to manage the lifecycle of bioanalytical and biomarker specimens and data in support of Takeda clinical trials. You will support the management of high quality clinical bioanalytical and biomarker data and driving the process for data transfer from CROs to Takeda data repository and releasing reconciled data to end users.  You will serve as a conduit to the broader organization to help develop a framework, best practices, and efficiencies to drive standardization and simplification to enable connection of the translational strategy with operational planning and execution.

How you will contribute:

    • The position requires working in close partnership across various Takeda functions including Translational Sciences within each Drug Discovery Unit and/or Therapeutic Area Unit, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance to build effective and strategic relationships.  
    • Experience managing multiple bioanalytical and biomarker deliverables for concurrent clinical trials is required and expected to contribute at a broad and strategic level.
    • 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 patient samples. Ensure standardization and harmonization of end-to-end biospecimen activities across clinical trials; maximize biomarker specimen accrual and quality. 
    • Candidate should have a working knowledge of various analytical methods including ligand binding assays, LC/MS, qPCR, flow cytometry and immunohistochemistry as well as a working knowledge of fit-for-purpose assay rigor (qualification, validation, etc) requirements needed to support clinical trial endpoints.   
    • Support the implementation, maintenance, and improvement of preferred provider models used for bioanalytical outsourcing. Partner with BST colleagues to develop efficient processes for execution of bioanalytical and biomarker activities with a solid understanding of Quality Assurance requirements to ensure vendor compliance and data integrity. 
    • Work with internal and external partners to develop processes and workflows for data flows, data mapping, data security and data QC as well as updating existing biomarker data standards for clinical trial studies.
    • Work with clinical teams to provide controlled terminology and mapping instructions for clinical biomarker data and to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.
    • Work with Translational Scientists and BST SMEs to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.
    • Interface with clinical project teams to mitigate issues with clinical biomarker data standards as well as with vendors to mitigate issues with clinical biomarker data transfers, security, and reporting.
    • Collaborate with Clinical Operations, clinical CRO, specialty and central laboratories to resolve sample and data reconciliation issues and maximize the quality of translational biomarker data as well as integrate clinical biomarker data sets with clinical EDC data for downstream biomarker data analysis.
    • Participate in initiatives around data hosting and suitability of various databases for biomarker data from different modalities.
    • Build and manage the BST network of specialty labs to support delivery of high quality bioanalytical and biomarker data to clinical programs, ensuring adherence to the requirements of quality, and ethical and regulatory standards.
    • Work with QA on specialty lab vendor activities (new supplier requests, routine audits, technical assessment management, risk/mitigation).
    • Work with Procurement on specialty lab vendor activities (onboarding, consolidation, RFI/RFP, pricing).
    • Responsible for specialty lab vendor management at the partnership level (resource management, escalations, governance).
    • Lead the coordination and support of audit and inspection preparation for both Takeda QA specialty lab audits as well as Agency inspections.
    • Responsible for communication and to follow-up on any relevant matters related to specialty labs, Procurement, or Quality deliverables at the partnership level.
    • Serve as a point of internal escalation for any specialty lab issues or critical path concerns that cannot be mitigated at the team level.
    • Partner with BST colleagues to develop efficient processes for execution of bioanalytical and biomarker activities with a solid understanding of Quality Assurance and geographical requirements to ensure vendor compliance and data integrity.
    • Participates in initiatives to create efficiencies and drive simplification in the execution of clinical testing paradigms.

    Minimum Requirements/Qualifications:

    • PhD degree in a scientific discipline with 10+ years experience , or MS with 16+ years experience, or BS with 18+ years experience.
    • 5 years of Industry experience required.
    • 5 years of managerial experience required.
    • Knowledge of drug development, clinical trial principles and understanding of the role of bioanalysis and biomarkers in clinical studies.  
    • Experience in sample and data management activities across multiple projects.  
    • Ability to work with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy.  
    • Excellent written, organizational, and interpersonal communications skills in order to efficiently and succinctly update the stakeholders and internal team members on progress, address questions and issues as well as interface with external vendors.  
    • Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling. Knowledge of regulations from other regions (e.g., China and Brazil) a plus.  
    • Experience with Labmatrix or equivalent sample management software is a plus.  
    • Proven critical reasoning skills including the identification and resolution of complex problems.  
    • Ability to be an effective member of multi-disciplinary project teams.

    More About Us:

    At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

    Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

    This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy. This position requires the candidate to come onsite to Cambridge location minimum 5x/month.

    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:

    Boston, MA

    U.S. Base Salary Range:

    $169,400.00 - $266,200.00

    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-termincentives. 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.

    Locations

    Boston, MA

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time
    Apply Now

    Where you fit in

    Our team at Takeda is tackling some of the most challenging problems in drug discovery and development. As the newest member of our Research team, you’ll conduct purposeful, meaningful work on groundbreaking modalities that may lead to breakthrough drugs.

    With our deep investment in next-generation technologies, you’ll have the resources and support to do your best work. As a part of our team, you’ll connect with brilliant minds inside and outside of Takeda. We are committed to collaborating with academia and emerging biotech companies to expand our reach and impact in cell therapy, gene therapy and data sciences.

    Our team’s wide-ranging expertise includes medicinal chemistry, genomics datasets, immunofluorescence, high content imaging, flow cytometry, transcriptional profiling, multi-step synthesis, multimodal genetics, pharmacokinetics and much more. Whatever area inspires you, your work will support the progression of an innovative, industry-leading discovery pipeline and make an impact that matters to patients and society.

    A career in Research at Takeda will give you everything you need to succeed professionally — and make a difference to patients, people and the planet.

    • Design and carry out experiments

    • Manage multiple projects

    • Document data

    • Mentor other scientists

    Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.

    Christina Alves - Head of Biotherapeutics Process Development

    I feel especially lucky to be able to work with colleagues across the industry to meet a unified goal.Takeda is paving the way for how research will be conducted in the future.

    Daniel Scheibe - Senior Manager Operations, Systems Engineering, Drug Discovery Sciences

    Our pipeline

    Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

    Learn more

    What we believe in

    Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

    Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

    We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

    Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

    • Integrity

    • Fairness

    • Honesty

    • Perseverance

    Working at Takeda

    • Inclusion

      Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
    • Collaboration

      A strong, borderless team, we strive together towards our priorities and inspiring mission.
    • Innovation

      Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
    • Top Workplace

      Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
    • Work-Life

      Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
    • Empowerment

      Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

    We're Steadfast In Our Commitment to Four Key Imperatives

    Patient


    Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

    People


    Create an exceptional people experience.

    Planet


    Protect our planet.

    Data & Digital


    Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

    Exterior of Takeda Building

    About our location

    Boston, Massachusetts


    View Map of Boston, Massachusetts

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